simplant® manual

Validated workflow with

Formlabs Form2 3D printers

Simplant®

ManualSimplant® Digital Guide

The 3D printed surgical guide has been validated for average designs of the Simplant Guide File and created in approved Simplant 3D planning and design software. If the customer chooses to design a 3D printed surgical guide with other than Simplant software, Dentsply Sirona cannot give any guarantee, and does not assume any liability for the performance of the surgical guide. If the customer chooses to use Simplant Guide Sleeves in a surgical guide printed from a different design than the Simplant Guide File, Dentsply Sirona cannot give any guarantee, and does not assume any liability for the performance of the surgical guide.

All products may not be regulatory cleared/released/licensed in all markets. Please contact the local Dentsply Sirona sales office for current product assortment and availability. Product illustrations are not to scale.

To improve readability, Dentsply Sirona does not use ® or ™ in body copy. However, Dentsply Sirona does not waive any right to the trademark and nothing herein shall be interpreted to the contrary.

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Simplant® Contents Product information 4 3D printed surgical guide 4 Simplant Guide File 5 Simplant Guide Sleeves 6Validated glue and equipment 9 Form 2 9 Form Wash 9 Form Cure 9Introduction to the Form 2 printer 10 Technical data 10 Product elements 11 Understanding the touchscreen 11Safety warnings 12 Component and Subsystem Safety 12 Laser 12 Laser Certification 12 Sharp Tools 12 Resin 12 Radio Interference 13 Isopropyl Alcohol (IPA) 13 Personal Protective Equipment (PPE) 13 Specifications of Tools to be Used 13Preparation, setup and maintenance of the Form 2 printer 14 Installing the Form 2 14 Unboxing the Form 2 14 Installing the Form 2 14 Level Printer 14 Insert Resin Tank with Wiper 15 Insert Build Platform 15 Insert Resin Cartridge 15 Connecting the Form 2 16 Maintenance of the Form 2 17Creating a new Simplant order 19Downloading Simplant Guide File and surgical guideline 21Importing Simplant Guide File into PreForm SW 22 Select Material 22 Import Model Files into Preform 22 Orient models 22 Generate Supports 23 Layout 24 Upload the print 24Printing the surgical guide 25 Prepare the printer and resin 25 Print 25 Wash 26 Drying 27 Removal of support 27 Adding the Guide Sleeve(s) 28 Cure with Form Cure 29 Removal of supports 30 Finishing 30 Quality Control 30 Steam Clean 30Additional requirements for lab-side printing 31 Labeling 31 Packaging and Shipping 31

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Product information

Depending on the solution, the surgical guide is always used together with other components. Make sure to check the applicable instruction for these other components.

Available solutions for the Simplant Digital Guide:

Simplant Guide manufactured at Dentsply Sirona: Tooth-, mucosa- or bone-supported

Simplant Digital Guide manufactured in your clinic: Tooth- or mucosa-supported

Caution:The Universal and the Pilot solutions are used with the Simplant LongStop Drill System instruments to obtain a vertical stop during drilling. When using other surgical instruments with these guides, drill depth control has to be obtained visually, taking into account the total drill length indicated on the surgical guideline.

SAFE solution• Guided drilling and guided

implant placement• Brand specific guided surgery

kit needed – Immediate temporization possible

Universal solution• Guided drilling only• Drill depth control only when

used in combination with Simplant LongStop drills

• Simplant Universal Drill Key set needed

Pilot solution• Guided drilling of the initial pilot

drill only• Drill depth control only when

used in combination with Simplant LongStop drills

Product information

Step 1: PlanScan patient anatomy and

create or approve the implant plan considering surgical and

restorative aspects.

3D printed surgical guide

Using Simplant Pro software or Simplant Planning Service, you can order Simplant Guides directly from Dentsply Sirona or for desktop 3D printing in your own clinic. Whatever your implant workflow preferences, you benefit from the same expert Simplant Guide design.

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Product information

Simplant® Guide File

Simplant Guide File is a digital representation of the Simplant Guide design. It enables specialist dentists or dental technicians to manufacture a surgical guide for dental implants. The manufacturing process requires gluing of the applicable guide sleeve(s) in the surgical guide prior to use.

A distinction is made between two versions of the Simplant Guide File:

• The Design Review version is the Simplant Guide File that is designed by the specialist dentist or dental technician with the FastTrack design option in Simplant Pro software. The FastTrack design is submitted via www.orderdigitalsolutions.com for central design review at Dentsply Sirona operations. This version of the Simplant Guide File is returned faster and incurs comparatively lower costs.

• The Full Design version is the Simplant Guide File that is designed centrally at Dentsply Sirona operations based on your planning in Simplant Pro software. Alternatively, this version of the Simplant Guide File can be designed centrally at Dentsply Sirona operations as part of a Simplant Planning Service.

Step 2: DesignReceive the Simplant

Guide File and import into the preparation software

for printing.

Step 3: Print & WashSend the prepared

Simplant Guide File to the Formlabs Form2 printer.

Step 4: Add SleevesGlue the Simplant Guide Sleeves into the printed

guide.

Step 5: CurePost-cure the guide with the Guide Sleeves glued in. Then

remove the supports and finalize the surgical guide.

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Simplant® Guide Sleeves

The Simplant Guide Sleeves are made of titanium alloy and are available in different models. The Simplant Guide Sleeves are indicated for single use and delivered non-sterile in sets of 10.

The responsibility for sterility of the Simplant Digital Guide (including its guide sleeves) lies with the end-user. For instructions, see the Instruction For Use.

Product information

ND (A implants) WD (B implants)

Guide Sleeve Type & Ø Inner Ankylos C/Guide-Sleeve Ø4.5 ND(10 pieces)

Ankylos C/Guide-Sleeve Ø4.9 WD(10 pieces)

Order No. 3183 0729 3183 0731

Guide Sleeve Type & Ø Inner Ankylos O/Guide-Sleeve Ø4.5 ND(10 pieces)

Ankylos O/Guide-Sleeve Ø4.9 WD(10 pieces)

Order No. 3183 0728 3183 0730

Ankylos

Xive Guide Sleeves

ND (3.0, 3.4 and 3.8 implants) WD (4.5 implants)

Guide Sleeve Type & Ø Inner Xive C/Guide-Sleeve Ø4.5 ND(10 pieces)

Xive C/Guide-Sleeve Ø5.2 WD(10 pieces)

Order No. 3183 0737 3183 0739

Guide Sleeve Type & Ø Inner Xive O/Guide-Sleeve Ø4.5 ND(10 pieces)

Xive O/Guide-Sleeve Ø5.2 WD(10 pieces)

Order No. 3183 0736 3183 0738

Astra Tech Implant System EV

ND (3.6 and 4.2 implants) WD (4.8 implants)

Guide Sleeve Type & Ø Inner EV C/Guide-Sleeve Ø4.6 ND(10 pieces)

EV C/Guide-Sleeve Ø5.2 WD(10 pieces)

Order No. 3183 0733 3183 0735

Guide Sleeve Type & Ø Inner EV O/Guide-Sleeve Ø4.6 ND(10 pieces)

EV O/Guide-Sleeve Ø5.2 WD(10 pieces)

Order No. 3183 0732 3183 0734

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Description Used for…

Guide Sleeve Type & Ø Inner Simplant C/Guide-Sleeve Ø2.0(10 pieces)

Simplant LongStop Drills Ø1.95

Order No. 3183 0743


EV Guide Fixation Screw

Order No. 3183 0751


Closed sleeve for Universal Drill Keys RP + Anthogyr + SIC + Thommen + Geass + Kentec

Order No. 3183 0747


Closed sleeve for Universal Drill Keys WP + Anthogyr + SIC + Thommen + Geass + Kentec

Closed sleeve for Straumann BLX implants, with VeloDrill self-locking drill key

Order No. 3183 0748

Guide Sleeve Type & Ø Inner Simplant C/Guide-Sleeve Ø5.0 S(10 pieces)

Closed sleeve for Straumannguided implants

Order No. 3183 0740

Guide Sleeve Type & Ø Inner Simplant O/Guide-Sleeve Ø4.2(10 pieces)

Open sleeve for Universal Drill Keys RP

Order No. 3183 0749

Guide Sleeve Type & Ø Inner Simplant O/Guide-Sleeve Ø5.2(10 pieces)

Open sleeve for Universal Drill Keys WP

Order No. 3183 0750

Guide Sleeve Type & Ø Inner Simplant C/Guide-Sleeve Ø4.2 N(10 pieces)

Closed sleeve for Nobel BiocareNP implants

Order No. 3183 0744


Closed sleeve for Nobel BiocareRP implants

Order No. 3183 0745


Closed sleeve for Nobel BiocareWP implants

Order No. 3183 0746

Other implants

For the design features of Simplant Pilot Guide - LongStop drill system and the design features of Simplant Universal Guide, please refer to the appropriate manual (the Simplant LongStop Concept).

Product information

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Product information

Description Used for…

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø3.3 CG(10 pieces)

Closed sleeve for CamlogGray, D3.3 implants

Order No. 68017210

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø3.8 CY(10 pieces)

Closed sleeve for CamlogYellow, D3.8 implants

Order No. 68017207

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø4.3 CP(10 pieces)

Closed sleeve for CamlogPink, D4.3 implants

Order No. 68017208

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø4.2 Z(10 pieces)

Closed sleeve for Zimmer Size A Drill Key

Order No. 68017211

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø5.3 Z(10 pieces)

Closed sleeve for Zimmer Size B Drill Key

Order No. 68017212

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø4.3 BY(10 pieces)

Closed sleeve for BiohorizonsYellow Drill Key

Order No. 68017213

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø5.1 BG(10 pieces)

Closed sleeve for BiohorizonsGreen Drill Key

Order No. 68017214

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve Ø6.3 BB(10 pieces)

Closed sleeve for BiohorizonsBlue Drill Key

Order No. 68017215

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve RP 3i(10 pieces)

Closed sleeve for Biomet 3iD4.0 Blue

Order No. 68017216

Guide Sleeve Type & Ø Inner Simplant Guide-Sleeve WP 3i(10 pieces)

Closed sleeve for Biomet 3iD5.0 Yellow

Order No. 68017217

For the design features of Simplant Pilot Guide - LongStop drill system and the design features of Simplant Universal Guide, please refer to the appropriate manual (the Simplant LongStop Concept).

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The following materials and equipment are needed for validated process of manufacturing Simplant Digital Guide. These components are not supplied by Dentsply Sirona:

• Loctite 4304 adhesive and gluing tips• Form2 printer• Dental SG resin• Resin Tank LT• Preform software version 2.19.0 or newer• Form Wash • Form Cure

Form 2The operating temperature for the Form 2 is 64–82 °F (18–28 °C). For optimal printing, do not exceed this range.

In chapter “Preparation, Setup and Maintenance of the Form 2 printer”, detailed instructions can be found to prepare, install and maintain the Form 2 printer.

Form WashIt is recommended to verify the washing solvent, IPA, with the hydrometer that comes with the Form Wash equipment. The hydrometer is calibrated according to the following instructions and will be used to check the resin concentration of IPA between washes.

Before measuring the concentration make sure the hydrometer (IPA only) is calibrated. Reference the components of the hydrometer according to the following names:

A: O-ringB: FloatC: HandleD: Tall wingsE: Short wingsF: Weight

To calibrate the hydrometer:

1. Hold the handle (A) and release the tool in the wash bucket’s fresh solvent.

2. Slide the O-ring (B) along the ribbed stem until the O-ring aligns with the short wings (C) at the top of the float.

3. Leave the O-ring in this position. The alignment of the wings and the O-ring is used to check the resin concentration of solvent between washes.

Store the hydrometer in the tool storage area at the back of the unit.

As the resin concentration of the IPA increases, the weight (F) on the hydrometer floats higher, and the stem and O-ring (A) on the hydrometer rise. When properly calibrated using fresh IPA, the O-ring (A) on the hydrometer should be level with the short wings (E) on the float (B). The hydrometer indicates when the resin concentration of IPA reaches 10–12%. If the O-ring (A) is higher than the tall wings (D), replace the IPA.

Form Cure

It is recommended to verify that the LED’s of the Form Cure are ignited after starting the post-curing operation.

Validated glue and equipment

Validated glue and equipment

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Introduction to the Form 2 printer

Form 2 Printer

Form 2 Finish Kit

Resin Cartridge

Form 2 Resin Tank

Form 2 Build Platform

Shipping Dimensions 18 x 18 x 27 in(46x46x68 cm

8 x 9 x 9 in(46x23x23 cm)

9.5 x 8 x 3 in(24x20x8 cm)

11.25 x 11 x 3 in(29x28x8 cm)

7 x 6.75 x 3 in(18x17x8 cm)

Shipping Weight 44 lbs(20 kg)

6.6 lbs(3 kg)

3.3 lbs(1.5 kg)

1.8 lbs(0.85 kg)

1.5 lbs(0.67 kg)

Product Weight 28.5 lb(13 kg)

5.7 lb(2.6 kg)

3-3.5 lb(1.35-1.6 kg)

1.4 lb(0.65 kg)

1.4 lb(0.65 kg)

Product Dimensions 13.5 x 13 x 20.5 in(35x33x52 cm)

Product Weight 28.5 lbs(13 kg)

OperatingTemperature

Auto-heats to 95° FAuto-heats to 35° C

Temperature Control Self-heating Resin Tank

Power Requirements 100 – 240 V1.5 A 50/60 Hz65 W

Sound Emission Does not exceed 70 dB(A).

Radiation Information The Form 2 is a Class 1 Laser product. Accessible radiation is within Class 1 limits.

Laser Specification EN 60825-1:2007 certifiedClass 1 Laser Product405 nm violet laser250 mW laser

Optical Path Protected

Connectivity Wi-Fi, Ethernet and USB

Ethernet Connectivity

RJ-45 Ethernet (10BASE-T/100BASE-TX) LAN PortUse a shielded CAT-5 Ethernet cable (not included).

Wi-Fi Connectivity Protocol: IEEE 802.11 b/g/hFrequency: 2.4 GHz, does not support 5 GHzSupported security: WEP, WPA

Printer control Interactive Touchscreen with Push-button

Technology Stereolithography (SLA)

Peel Mechanism Sliding Peel Process with wiper

Resin Fill System Automated

Build Volume 5.7 x 5.7 x 6.9 in145x145x175 mm

Layer Thickness(Axis Resolution)

25, 50, 100 microns0.001, 0.002, 0.004 inches

Laser Spot Size (FWHM)

0.0055 inches140 microns

Supports Auto-GeneratedEasily Removable

Technical data


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Product elements

1. Cartridge 2. Cover 3. Build Platform 4. Resin Tank 5. Wiper 6. Touchscreen 7. Button 8. Leveling Tool

Understanding the touchscreen

The Form 2 display includes a touchscreen and button.

The LCD touchscreen displays print information, settings, and error messages. It serves as the user interface for the Form 2.

The push button starts and pauses prints when prompted by the touchscreen. Hold the button to wake and sleep the printer. A light surrounding the button flashes when the printer is ready to start a print. Press the button to start or stop a print.

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Safety warnings

Safety warningsCautionRead and understand this manual and its safety instructions before using the Form 2. Failure to do so can result in serious injury or death.Supervise young or inexperienced users to ensure enjoyable and safe operation. The instructions contain warnings and safety information, as explained below:

DangerDanger indicates a hazard with a high level of risk which, if not avoided, will result in death or serious injury.

WarningWarning indicates a hazard with a medium level of risk which, if not avoided, could result in death or serious injury.

Accessible radiation is within Class 1 limits. The laser diode used inside the device has the following specifications:

Diode: Violet (405 nm) Max Output: 250 mW

The laser beam is harmful to the eyes, so avoid direct contact. The Form 2 contains an interlock system to automatically shut off the laser when the cover is open. If this system is tampered with or fails, there is a risk of exposure to Class 3B laser light.

Laser Certification:

IEC 60825-1:2007 EN 60825-1:2007

FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007

The accessories include sharp tools such as: tweezers, flush cutters, a scraper, and a part removal tool. Using these tools on slippery surfaces (such as a resincoated build platform) can result in sudden movement.

Resin

Respect Formlabs resin like any household chemical. Follow standard chemical safety procedures and Formlabs resin handling instructions.

In general, Formlabs resin is not approved for use with food, drink, or medical applications on the human body. However, biocompatible resins, such as Dental SG, are biologically safe for specific types and lengths of exposure to the human body. Refer to information about each specific resin for more detail.

Class 1 Laser Product. Only remove the shell of the printer with authorization fromFormlabs or a certified reseller. Always disconnect power before removing the shell.

Wear gloves whenever handling liquid resin.

Never ingest resin in liquid or solid form

CautionCaution indicates a hazard with a low level of risk which, if not avoided, could result in minor or moderate injury.

NoticeNotice indicates information considered important, but not hazard-related.

WarningThe laser beam is harmful to eyes. Avoid direct contact.

WarningIsopropyl alcohol is a flammable chemical.

Component and Subsystem Safety Sharp Tools

Laser

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Safety warnings

Radio Interference

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to CFR Title 47, Part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense. Changes or modifications to this product not authorized by Formlabs could void the electromagnetic compatibility (EMC) and wireless compliance and negate your authority to operate the product.

This product has demonstrated EMC compliance under conditions that included the use of compliant peripheral devices and shielded cables between system components. It is important that you use compliant peripheral devices and shielded cables between system components to reduce the possibility of causing interference to radios, televisions, and other electronic devices.

Personal Protective Equipment (PPE)

Isopropyl Alcohol (IPA)

Carefully follow the safety instructions provided with the isopropyl alcohol that you purchase. Isopropyl alcohol can be flammable, even explosive, and should be kept away from heat, fire, or sparks. Any containers holding isopropyl alcohol should be kept closed or covered when not in use. We also recommend that you wear protective gloves and have good ventilation when working with IPA.

Specifications of Tools to be Used

The Form 2 shall only be used with supplied accessories and additional tools recommended by Formlabs. Third-party accessories and materials may cause damage.

Purchase additional supplies:

• Keep paper towels in stock to ensure a clean work environment for printing and finishing.

• Isopropyl alcohol (IPA, 90% or higher) is the recommended solution for rinsing parts and cleaning liquid resin after each completed print.

• Use a shielded CAT-5 Ethernet cable to connect the printer to a local network.

• Disposable chemical resistant gloves (nitrile or neoprene)

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

Always wear clean gloves when handling resin or resin-coated surfaces.

Some methods of support removal may enable small pieces of supports to break away. Beware of flying debris and consider wearing eye protection and gloves to protect the skin and eyes.

Always wear clean gloves when handling optical surfaces.

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Preparation, setup and maintenance of the Form 2 printer

Installing the Form 2

Choose a stable, level workspace to install and operate the Form 2. Reserve the following minimum dimensions for the most convenient access:

Width: 36 cm Depth: 43 cm Height: 76 cm

Allow additional space for accessories, such as the Form 2 Finish Kit, Form Wash, and Form Cure

Unboxing the Form 2

To unbox the Form 2:

1. Remove the top foam packaging insert.

2. Use the provided handles to lift your printer from the box.

3. Remove the printer from the carrier tray and set in workspace.

During unboxing, inspect the Form 2 for any damage or missing items. In the case of damage or missing items, contact Formlabs or the authorized reseller.

Installing the Form 2

Connect Cables

Connect the power cable to the printer and the power supply. Files can be uploaded via USB, Wi-Fi, or Ethernet. For USB, connect the printer to a nearby computer. For Ethernet, connect the printer to an Ethernet port.

Level Printer

The Form 2 must be completely level before printing can begin. If prompted, use the leveling tool to raise or lower each foot of your printer. To level the Form 2:

The Form 2 includes three connection ports on the back panel. From left to right: Ethernet, USB, and power. The power connection is shown in the inlaid image.

Remove all packaging material before connecting power. Lift the cover to remove the protective shipping material from the resin tank carrier.

With the Form 2 set up and connected, press the button once to power the printer on. If necessary, the touchscreen prompts use of the leveling tool.

Follow the on-screen instructions to adjust the feet under the printer. With the round leveling tool installed under the designated corner, rotate the tool clockwise to raise and counter-clockwise to lower the height of the printer.

Adjust the feet until the circle is aligned on the screen.

It is important that the printer sits level so resin does not overflow from the tank during printing.

Save the Form 2 packaging for transporting your printer. Original packaging is required for warranty service.


Consider the weight and dimension of the product for installation.

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Insert Resin Tank with Wiper

Insert Resin Cartridge

Insert Build Platform

Lift the printer’s cover. Remove the resin tank’s black lid.

Align the four small feet of the resin tank into the corresponding holes in the tank carrier

Push the tank until it is flush against the front of the tank carrier. The printer will not properly detect the tank unless the tank is fully inserted.

Before inserting a new cartridge, shake the cartridge to ensure the resin is mixed thoroughly. Shake the resin cartridge approximately every two weeks to keep the formula well-mixed for the best print quality.

Remove the orange protective valve cover from the underside of the cartridge. Consider saving the cover to protect the valve during storage.

Align the cartridge with the opening in the back of the printer.

Push down on the cartridge handle until the top of the cartridge is level with the printer.

Align the build platform with the platform carrier.

Push the build platform onto the platform carrier.

Lock the handle down to secure the build platform.

Lock Wiper

Ensure the wiper is straight.

Align the foot of the wiper with the wiper mount.

Push the wiper toward the tank to align it with the front of the mount. The wiper should be firmly mounted

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1

5

2

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4

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2

b

a

4

c

Manually slide the wiper mount to the center before removing a resin tank.

Do not remove the rubber valve at the bottom of the cartridge. This bite valve controls the release of the resin. Removing the rubber bite valve would allow resin to continuously flow and cause extreme damage to the machine. Remove the orange valve cover from the underside of the cartridge, and press open the cap before starting a print, so that the resin tank fills correctly.

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Plug one end of the USB cable in the back of the Form. Connect the other end to a computer’s USB port.

Plug one end of the Ethernet cable into the back of the Form 2.

Connect the other end to your LAN.

With an established Ethernet or available Wi-Fi connection, open the printer’s Settings menu on the touchscreen.

For Wi-Fi networks, select Wi-Fi, then the desired wireless network.

For Ethernet connections, simply open Ethernet from the Settings menu.

Toggle the Manual IP settings to ON.

Input the appropriate IP Address, Subnet Mask, Default Gateway, and Name Server.

To connect to Wi-Fi, touch Wi-Fi on the settings tab on the touchscreen.

Select the name of the network you would like to connect to.

Enter the password for that Wi-Fi network using the onscreen keyboard.

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Connecting the Form 2

Connect to the Form 2 to upload and manage prints over Wi-Fi, USB, and Ethernet. The Form 2 can connect directly to a computer with the included USB cable. For remote uploading and monitoring, the Form 2 supports both wired (Ethernet) and wireless (Wi-Fi) connections. Connect PreForm print preparation software to the same local-area network (LAN) as the printer in order to send a print job.

For a Windows operating system, after installing PreForm, check to ensure that Bonjour is properly installed. Bonjour is a third-party software that is required to connect over Wi-Fi or Ethernet. The USB connection can still be used while the Form 2 is connected to a LAN.

When the Form 2 is connected to a LAN, its current status and print progress can be monitored with Dashboard: formlabs.com/dashboard.

To connect with USB:

Use the included USB cable for connecting a computer directly to the printer.

To connect with Ethernet:

The rear of the unit is equipped with a RJ-45 Ethernet (10BASE-T/100BASE-TX) LAN Port. Use a shielded CAT-5 Ethernet cable (not included) to connect the printer to a local network.

To connect with Wi-Fi using a manual IP configuration:

When connected to an active Ethernet connection or available Wi-Fi network, the Form 2 can be configured with a static IP address.

To connect with Wi-Fi:

The Form 2’s built-in Wi-Fi (IEEE 802.11 b/g/n) supports WEP and WPA security. Use the Form 2’s touchscreen to configure a wireless network connection. The Form 2’s Wi-Fi feature does not support 5 GHz connections.

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Perform the following preventive and curative maintenance on the Form 2.

Maintenance of the Form 2

Schedule

System Inspection Maintenance ONLY if problems are noted:

Est. Time

Frequency Incidental D M I

Optical window

Inspect the optical glass for contamination,including dust, resin, spots, streaks, clouding,fingerprints, etc.

If possible, clean the glass optical window with dry photographic wipes (PEC*PADs). Over-cleaning and over-use of IPA can degrade the glass surface. If dry wipes are not sufficient, you may apply small amounts of IPA to the photographic wipe to help loosen up surface contaminants. Lay the wipe flat against the glass and wipe in a straight line from one side to the other slowly. Repeat in overlapping wipes until the surface is clean.

0.2 hr Daily Perform this check after a resin spill. Perform this check when the guide sleeve does not fit the surgical guide or when the surgical guide does not fit on the model

X X

Resin tank

Use a plastic scraper to gently inspect the tank for cured resin adhered to the bottom or loosely mixed into the liquid resin.

Using the scraper, gently dislodge cured resin from the bottom of the resin tank. Do not gouge or scratch the tank window. Because resin chunks can be mixed with the liquid resin and cannot be removed manually, empty the resin from the tank and inspect the tank to make sure it is clean and no remaining cured material is left behind.

0.2 hr Daily Perform this check before each print. Perform this check when the guide sleeve does not fit the surgical guide or when the surgical guide does not fit on the model.

X X

Resin tank

Use the wiper to sweep any liquid resin to the side and inspect the transparent bottom for signs of damage, pitting, clouding, spotting, or ripples.

Replace the resin tank if there is any sign of physical damage. If clouding, spotting, or ripples are evident, this could impact print quality. Monitor print quality and replace the resin tank if print quality declines.

0.1 hr Daily Perform this check if print quality issues are detected or if there are indications of resin leaking onto the optical window. Perform this check when the guide sleeve does not fit the surgical guide or when the surgical guide does not fit on the model.

X X

Resin tank

Carefully inspect the transparent underside of the tank for signs of contamination, fingerprints, or smudges.

The underside of the bottom layer can be gently cleaned using photographic wipes (PEC*PADs) and isopropyl alcohol. Transfer the resin in the tank to a separate opaque resin-safe container before cleaning. Place the wipe flat on the underside of the tank window and wipe slowly from one side to the other in a straight line. Repeat in overlapping straight lines until the entire window is free of streaks or other optical contamination.

0.2 hr Incidental Perform this check before inserting a resin tank into the Form 2. Perform this check when print quality issues are detected, when the guide sleeve does not fit the surgical guide or when the surgical guide does not fit on the model.

X

D = Daily, M = Monthly, I = Incidental

For detailed instructions on how the perform the maintenance tasks, please contact [email protected].

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Schedule

System Inspection Maintenance ONLY if problems are noted:

Est. Time

Frequency Incidental D M I

Build platform

Inspect the build platform for liquid resin, tackiness, or cured resin on the print surface.

Use isopropyl alcohol to remove any liquid resin or tackiness. Use a scraper to remove any cured resin.

0.1 hr Daily Perform this check before each print.

X X

Resin cartridge

Inspect the resin cartridge thoroughly for signs of leakage, especially around the cartridge skirt and the rubber bite valve.

Do not use the resin cartridge if a leak is noted. Place the resin cartridge in a plastic bag and contact Formlabs Services.

0.1 hr Incidental Perform this check before inserting a resincartridge into the printer.

X

Resin cartridge

Check to see if the resin is more than 24 months old. The production date is located on a white sticker on the bottom of the cartridge.

Discard expired resin. 0.1 hr Incidental Perform this check before inserting a resincartridge into the printer.

X

Optics Run an optics test print. Wash and dry once completed. Inspect each printed part for signs of optical degradation. Each of the four columns should have sharp angles and the numbers should be crisp. The center object should have crisp details in the slits and vertical rods.

If uniform optical degradation is noted, this could be an indication that the internal optical surfaces need to be cleaned. Contact Formlabs Services for assistance. Be sure to provide photos of the optics print test. Non-uniform defects indicate a problem with the optical window or resin tank. Perform checks on both systems.

2.0 hr Monthly Perform this test after resin spills or extensivecleaning procedures.Perform this check when the guide sleeve does not fit the surgical guide, when the surgical guide does not fit on the model.

X X

D = Daily, M = Monthly, I = Incidental

For detailed instructions on how the perform the maintenance tasks, please contact [email protected].

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Creating a new Simplant® order for your case

Creating a new Simplant® order for your caseThe first step in ordering a Simplant Guide File is to request a Simplant Guide for your implant planning in the Simplant Pro software or to create a Simplant Planning Service order on www.orderdigitalsolutions.com

For more flexible design and ordering options, as well as a faster turnaround of the Simplant Guide File, it is recommended to use the Simplant Pro software.

On the “Prescription” page, specify the options for your order and select “Simplant Guide File” as the manufacturing choice.

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Creating a new Simplant® order for your case

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If you do not have the applicable guide sleeves in stock yet, you can add 1 or more sets of Simplant Guide Sleeves before submitting the order.

Simplant Guide Sleeves can also be ordered separate from the Simplant case planning via the Dentsply Sirona sales rep or web shop.

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Downloading Simplant® Guide File and surgical guideline

Downloading Simplant® Guide File and surgical guidelineA notification will be sent when the Simplant Guide File is available for your order. Follow the link in the notification email to the order details page.

Download and save the Simplant Guide File and the surgical guideline on your computer:

Before proceeding, note down the Order ID of your planning and verify that all case files display the same Order ID:

* The Simplant Guide File name starts with the correct Order ID* Open the surgical guideline and verify the Order ID in the top left section matches

the Order ID of your planning* Open the Simplant Guide File and verify that the ID print on the guide design

matches the last 4 digits of the Order ID of your planning

Use the Simplant Guide File for further pre-processing and manufacturing of the surgical guide.

Use the surgical guideline to verify guide sleeve information for the different implant positions when manufacturing the surgical guide. In addition, this surgical guideline includes the steps to follow for the case-specific drilling sequence and is an important document to accompany the surgical guide for the surgical intervention.

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Importing Simplant® Guide File into PreForm SW

Importing Simplant® Guide File into PreForm SWSelect Material

Open PreForm.

Opening PreForm, you will see the boundaries of the build volume and the build platform, which is inverted from the print direction. Select “Dental SG” from the Material menu and set the layer thickness to 0.05mm before configuring the model.

Import Model Files into Preform

Import the Simplant Guide File (STL file) into Preform.

The build volume (145 × 145 × 175 mm) is displayed by the PreForm software after the printer (Form 2) is selected. The build volume indicated by the PreForm software can be used for placement of the Simplant Guide File.

The selection of the Dental SG material will define the build path used for printing the Simplant Guide File.

Orient models

The Simplant Guide File should be oriented at an angle of +70° or -70°, always placed with the patient-contacting surfaces facing away from the build platform to ensure that supports will not be generated on these surfaces.

Orient parts such that no supports are generated inside or near the sleeve cavities.

A layer thickness of 0.05mm results in optimal print quality.

A build orientation of 70° allows to, later in the manufacturing process, insert the Simplant Guide Sleeves in the printed surgical guide while the support structures are still attached to the guide. Curing of the guide and the glue can than happen simultaneously with support structures attached to the guide to avoid deformation.

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Generate SupportsGenerate supports using PreForm’s auto-generation feature with the Density set to 0,7 and the Touchpoint Size to 0,6mm.

To allow for simple and precise assembly, ensure that there are no supports (white dots) on the patient-contacting surfaces. Use the manual support editing feature to closely inspect support locations and add or remove supports as needed.

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Layout

When bundling several parts on the build plate, move the supported prints to their final location on the build plate. The full build area can be used for positioning the parts. Ensure a minimum distance of 0.5 mm between parts.

Upload the print

When the printability indicator is changed to a check mark, save the print as a FORM file and send the print job to the printer. Select which printer to upload the file to from the printer dialogue.

To allow for simple and precise assembly, ensure that there are no supports on the inner side or in the inside of the guide sleeve opening. Use the manual support editing feature to closely inspect support locations and add or remove supports as needed.

For open guide sleeves: make sure the only gluing channel lies free of supports. To reach the gluing channel with the glue, the gluing tips should not be blocked by the printed support structures.

Areas in need of support are highlighted in red on your model. If some parts of a model are highlighted in red as undersupported, add individual supports

No support attachments allowed in the red zone

Support attachments are allowed in the green zone

Avoiding Supports on the patient contacting surface and the inside of the guide sleeve openings will eliminate the need for postprocessing and ensure a smooth and untouched surface where needed.

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Printing the surgical guide

Printing the surgical guidePrepare the printer and resin

Before each print Inspect the Resin Cartridge Bite Valve and inspect and clean the Resin Tank LT. To inspect the bite valve: The bite valve is located under the resin cartridge. This flexible seal regulates resin dispensing. Resin flows out of the opening in the center of the bite valve when the cartridge dispense arm squeezes the valve open.

To inspect and clean the Resin Tank LT interior:

1. Empty resin from the tank using gloved hands and a spatula with rounded corners. Dispose of the resin.

2. Use a spatula with rounded corners to inspect the film-coated elastic layer. Starting from the top corner, gently scrape the spatula from top to bottom across the tank interior.

3. Check for the following issues that may lead to print failures or damage that require replacing the tank:

a. cured resin on the protective film

b. punctures or gouges in the protective film.

4. Check the clear acrylic window on the underside of the tank for fingerprints, dust, contamination, and scratches, which cause the laser light to diffuse and lead to print failures or inaccuracies. In the case of scratches on the resin tank window replace the Resin Tank LT.

5. Build Platform: Inspect the build platform for liquid resin, tackiness, or cured resin on the print surface.

6. Optical Window, located below the tank: After removal of the resin tank, inspect the optical glass for contamination, including dust, resin, spots, streaks, clouding, fingerprints, etc.”

Print

Confirm Print on Printer

1. From the home or print queue view, the Form 2’s touchscreen displays the FORM file’s upload in progress.

2. Select the file name.

3. Select Print.

4. Confirm the print by pushing the button.

5. Follow the onscreen prompts. The Form 2 automatically fills and warms the tank. The print starts automatically.

Pre-Print Checks

Before printing, the resin tank fills and heats to around 35 °C. The print starts automatically once the tank is full. The Form 2 regulates the volume of resin in the tank through a sensor called the LevelSense board, which is located behind the resin tank. The printer begins to fill the resin tank once a print starts and maintains the level of resin in the tank during the print.

Checking and Maintaining the Resin Temperature

The Form 2 heats resin to a set temperature before starting. Resin is heated from the metal tank carrier below the resin tank, and the resin temperature is sensed by an infrared sensor behind the resin tank. The Form 2 automatically preheats and maintains a consistent resin temperature before and between print jobs. View the resin tank’s current temperature on the Printer tab of the Form 2’s touchscreen.

The tank carrier acts as a heating element and can become very hot during the printing process. If the resin tank is removed immediately after printing, do not touch the tank carrier until the temperature reaches room temperature.

For full compliance and biocompatibility, Dental SG requires a dedicated Resin Tank LT, Build Platform, and Finish Kit, which should only be used with other Formlabs biocompatible resins, such as Dental LT Clear.

Emptying the resin tank ensures the surgical guides to be printed with virgin material and thus avoids debris and re-use of material.

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Wash

Place the build platform, with surgical guide still attached, in a Form Wash filled with isopropyl alcohol (IPA), 96% or higher. Set to wash for 5 minutes to wash the part and remove liquid resin.

Remove part from the build platform with the part removal tool. Verify that the parts are hard to ensure that the correct print parameters have been used.

Place the part in the metal basket. Set to wash for 5 minutes to wash all remaining liquid resin before post-curing.

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Only remove supporting structure to clear the guide sleeve openings: during post-curing the supporting structure should be attached to the guide to ensure stability.

Drying

Leave parts to air dry completely or use a compressed air hose to blow IPA away from surfaces. Inspect parts closely to ensure all uncured resin has been removed. Ensure that parts are clean and dry, with no residual stickiness. Repeat wash if necessary, but do not leave parts in IPA for more than 20 minutes, as this may reduce mechanical performance and cause defects in the printed parts.

Removal of supportRemove the supporting material in front of the guide sleeve openings by using plyers.

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Adding the Guide Sleeve(s)

The guide sleeve(s) according to the case-specific guide design are inserted in the surgical guide. For each planned implant position, consult the guide sleeve information in your planning or on the Simplant surgical guideline if applicable.

For easy insertion of the guide sleeve(s), place the guide on a flat surface facing upward and use an insertion tool slightly smaller in size than the guide sleeve diameter. Put the guide sleeve onto the insertion tool and press the sleeve into the guide. The guide sleeve(s) should fit into the guide without excessive force.

There should not be any deviation in angulation between the inserted guide sleeve and the guide sleeve opening in the surgical guide (visual check). The guide sleeve should be flush with the top of the guide sleeve opening (visual check). Use magnifying aids like microscope or camera to make sure that the guide sleeve is in the correct position.

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Use Loctite 4304 glue and gluing tips to attach the guide sleeves in the guide. An applicable gluing tip is the Tapered Tip 20 Gage - Pink (PK50). Insert the gluing tip in the gluing channel on buccal and lingual side of the guide sleeve opening and add adhesive. Make sure the adhesive is flowing completely around the guide sleeve. Excessive adhesive that is flowing out of the gluing channels or guide sleeve opening should be wiped off with a tissue.

Cure with Form CureParts must be fully post-cured by exposure to UV light and heat for biocompatibility and optimal mechanical properties. Place the printed guide(s) inside Form Cure. Post-cure for 30minutes at 60 °C.

A color change from translucent yellow to a uniform translucent orange will occur.

Printed Post-cured

Visible-light curing will not post-cure the material.

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Removal of supports

Use flush cutters (included in the Formlabs Finish Kit) to carefully cut the supports at the points where they attach to the part. Use caution when cutting the supports, as the post-cured material may be brittle. Safety goggles are recommended. Supports can also be removed using other specialized appliances, such as cutting disks or round cutting instruments like carbide burs.

Use standard (commercially available) sandpaper to smoothen the edges and remove sharp parts on the guide.

Finishing

Use cutting tools, such as carbide burrs, for finishing the guide and the model:

• removal of sharp edges

• reducing the guide dimension to support only on ½ of last teeth for better visibility of the fit of the guide on the model

• removal of material on the guide that results from extraction wounds

• removal of interdental material, at the same time making sure that tightness of the guide on the model is maintained

• removal of material on the model in case the metal sleeve sticks out of the guide and prevents a good fit of the guide on the model

Quality Control

As a final quality control the guide should be fitted onto the physical model.

• The borders of the surgical guide should be smooth, no sharp edges

• Guide should allow the handpiece to be used up to the correct depth. Verify there is no blockage of the drill head by neighbouring teeth.

• Guide should be hard, not flexible or soft (fully cured)

• Guide should not be fragile by design or overcuring (increases brittleness)

• Guide surface should appear smooth, without ‘steps’ by shifted layers in its contours.

• Guide’s unique ID (4 digits) should be readable.

• Guide’s resin surface around the guide sleeve should be free from support remainders (flat), as this area acts as a reference in case a drill key is used.

• Verify if important anatomical parts are not missing by chipped resin parts.

• Finally, check the guide fit on the physical model.

- no space visible by the naked eye between the guide and the model (illumination level of 750 lux minimum at the inspection surface)

- guide doesn’t wobble on the model

If the guide does not meet the above criteria, the guide cannot be used and it is recommended to reprint or redesign.

Steam Clean

Steam clean the surgical guide for 25 seconds. The surgical guide must be clean (without dust or other particles) as visibly seen with the naked eye (illumination level of 750 lux minimum at the inspection surface).

Apart from the finishing procedurementioned above, do not alter the patient-specific contacting surface of the guide.

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Additional requirements for lab-side printing

Additional requirements for lab-side printingIt is the responsibility of the local guide manufacturer that the guide is properly labeled, documented (Instructions for Use - IFU) and packaged for delivery to the end user.

The Instructions for Use - IFU - is available on the Dentsply Sirona website.

Go to: http://ifu.dentsplysirona.com

Click on “IFU - Current valid”. You can then choose “Filter Results” to search the Simplant brand or you can use “simlant guide file” in the free text search field.

Labeling

Label the guide according to the applicable regulation for medical devices.

The label should contain the following information as a minimum, in the appropriate language:

• Order ID• Expiry date (2 weeks after the production date)• Manufacturer’s address• Reference to Instructions for Use• Single Use• Non sterile• Keep away from sunlight• Keep dry

Packaging and Shipping

Package the labeled guide and model together with the Simplant surgical guideline and Instructions for Use and send to the clinician. Verify that the order ID printed on the guide corresponds to the order ID on the Simplant surgical guideline. Choose packaging that offers sunlight and humidity protection and packaging that is validated for ASTM D4169 DC13 transport test or equivalent.

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About Dentsply Sirona Implants

Dentsply Sirona Implants offers comprehensive solutions for all phases of implant therapy, including Ankylos®, Astra Tech Implant System® and Xive® implant lines, digital technologies, such as Atlantis® patient-specific solutions and Simplant® guided surgery, Symbios® regenerative solutions, and professional and business development programs, such as STEPPS™. Dentsply Sirona Implants creates value for dental professionals and allows for predictable and lasting implant treatment outcomes, resulting in enhanced quality of life for patients.

About Dentsply Sirona

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. As The Dental Solutions Company™, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry. Dentsply Sirona’s global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

THE DENTAL SOLUTIONS COMPANY™

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