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Instructions for Sterilizationand Instrument Care

ANKYLOS®

FRIALIT®/XiVE®

FRIOS®

2

General Requirements for the Use of Medical Products

Annotations for the Preparation ofDENTSPLY Friadent CeraMed (DFC) Products

• All dental implants by DFC are intended for single use only and must not be sterilized.

• For medical products which are not produced by DFC, please check the manufacturers’ guidelines regarding preparation and recycling. Please check the product label for further information on the manufacturer.

• All separatable parts must be disassembled for cleaning and disinfection, prior to reassembly, sterilization, storage, and reuse.

• If an ultrasonic cleaning solution is used, the drills must be placed in a bur organizer.

• Please follow legal regulations, as well as the hygienic guidelines for practices and clinics. In particular, please heed the guidelines regarding effective inactivation of prions.

• The constant risk of contamination and infection must be excluded or reduced through prevention.

• Judgement of the risks and dangers in connection with the medical treatment and definition of appropriate precautions.

• Schematization and systematization of work routines with the predominant aim to avoid contamination and injuries.

• Follow OSHA’s “universal precautions” for cross contamination.

• Both used and openly displayed medical products/devices should be considered contaminated, and must be sterilized prior to use. During medical product/device transport, care must be taken not to put staff or third parties at risk. For their own safety, staff members must wear appropriate protective clothing and gloves when using and handling medical products/devices.

• Medical products/devices should not be stored in physiological saline solution, as longer exposure may cause corrosion. Individual parts must be completely submerged in a bubble-free bath during disinfection. Demineralized water is required for the final rinse, after disinfection. Demineralized water can prevent water staining and crystal seeding, which may prohibit the proper sterilization process or accelerate corrosion.

• Please remember that you are responsible for the sterility of all of your medical products/devices. It is important to only use validated cleaning, disinfection, and sterilization procedures. All equipment you use should be serviced at regular intervals and all validated parameters must be followed during each cleaning, disinfection, and sterilization procedure. Always observe the manufacturers’ shelf-life for all products/devices.

• Every cleaned, disinfected, and sterilized package should display the sterilization date.

3

Validated* Sterilization Procedure forDENTSPLY Friadent CeraMed Medical Products

1. Pre-Disinfection (avoidance of cross contaminations)Place all medical products/devices in an ultrasonic germicidal bath** immediately after use. Remove all residues and disassemble instruments. Refer to pages 11-16 for disassembly instructions.

2. CleansingAlways use demineralized water and neutral cleansing solutions.** The internal irrigation tube should be cleaned with a “Miller” needle, and must be rinsed with distilled water at the beginning and the end of the exposure time using a disposable syringe (min. 10ml). Individual parts must be cleaned with a plastic cleaning brush and then rinsed with demineralized water. Please control all products after the cleansing process in order to avoid damage or corrosion. Damaged products must be replaced.

3. DisinfectionPlace all individual parts in an ultrasonic germicidal bath.**

4. Rinsing and DryingFor best results, after removing all individual parts from the ultrasonic germicidal bath, each individual part should be rinsed three times with demineralized water. Dry all individual parts thoroughly with a lint-free, disposable cloth. Use oil-free, compressed air when drying internally irrigated parts. Always check all parts for damage or corrosion after rinsing and drying.

5. Preparation for SterilizationPlace all medical products/devices in their designated tray. Seal the sterilizable tray or place the individual parts in a sterile package that is compatible with steam saturation.

6. SterilizationThe medical products/devices are sterilized in the autoclave for 7 minutes at 132° C (270° F) or for 20 minutes at 121° C (250° F) – these are the minimum holding times, the cycle time is longer and may vary depending on the type of device used.

7. StorageStore the dry, sterilized parts at room temperature.

* The sterilization procedure was validated according to the following guidelines:1. DIN EN ISO 1764: Sterilization of medical products2. RKI guideline: Hygienic requirements for the preparation of medical products (Bundesgesundheitsblatt 44:1115-1126)

** Please observe all manufacturers’ guidelines for disinfection and cleansing solutions with special regard to the concentration, exposure time, and temperature. Only neutral disinfection solutions without chlorine, ammoniac, and aldehydes and with a proven effectiveness against HBV, HCV, and HIV must be used. The products have tomeet the respective national regulations for disinfectants (e.g. FDA approval, DGHM listing, CE marking). If disinfectants containing aldehydes are used, this might lead to a possible fixation of proteins. Please use only freshly prepared solutions.

IMPORTANT!

All medical products/devices that are delivered non-sterile must be preparedaccording to the manufacturers’ guidelinesprior to and after every usage.

If a deviating procedure is utilized, it mustbe validated by the practice or clinic.

For information on the reusability of medicalproducts, please check the product label andthe following list. Disposable products aremarked with 2 on the label. Products whichare not suitable for a sterilization in saturat-ed steam due to their composition must bedisinfected prior to use. Refer to pages 6-10for a list of medical products sterilization/disinfection classification, andpage 3 for disinfection procedures 1-4 (pre-disinfection – Rinse and drying) andprocedure 7 (Storage). Thedisassembly/assembly of products and trays is described on pages 11 to 14.

4

Preparation of Surgical and Prosthetic Kits

Surgical kits must be cleaned, disinfected, and sterilized after each use. Please disassemble the kits according to the following instructions:

• Remove all the instruments from the Surgical/Prosthetic Kits and prepare them accordingly (page 3 and pages 6 -16).

• Remove the aluminum-base plate and any instrument locators from the Surgical/Prosthetic Kit for separate cleaning, following procedures 1-4 (page 3) prior to sterilization.

IMPORTANT!

• The clear cover in ANKYLOS® Surgical Kits should be discarded and must not be sterilized with the surgical kit.

• The tub-shaped box in FRIALIT and XiVE Surgical Kits is not a sterile container.

ADDITIONAL NOTES:

• When using the ANKYLOS Surgical Kit, always disassemble the instrument locators from the aluminum-base plate and follow procedures 1-4 (page 3) prior to sterilization.

• Remove and replace sterile filter in the ANKYLOS Surgical Kit prior to sterilization.

• Sterile filter is only required if storing in a pouch-less/unwrapped state. Note, sterile filter will maintain apouch-less sterile state for a maximum of 30 days.

• After the Surgical/Prosthetic Kit has been prepared (page 3 procedures 1-4), assemble required instrumentsin kit prior to sterilization.

5

List of Surgical and Prosthetic Kits

ANKYLOS® Material

ANKYLOS Prosthetic Tray (complete/for Balance or Standard Systems) Aluminum/Synthetics

ANKYLOS Prosthetic Kit Mini Tray Synthetics

ANKYLOS Recovery Tray Aluminum/Synthetics

ANKYLOS Surgery Tray BoneCondenser Aluminum/Synthetics

ANKYLOS Surgery Tray BoneExpander Aluminum/Synthetics

ANKYLOS Surgery Tray Direction Gauge Aluminum/Synthetics

ANKYLOS Surgery Tray for A + B + C Implants Aluminum/Stainless Steel/Sterile Filter

ANKYLOS Surgery Tray for D Implants Aluminum/Synthetics

ANKYLOS Trial Abutment Tray Standard Abutments Aluminum/Synthetics

ANKYLOS Tray Sinus Lift Instruments Aluminum/Synthetics

FRIADENT®

FRIADENT Prosthetic Set Mini Tray Synthetics

FRIADENT Tray for Torque Ratchet Aluminum

FRIALIT®

FRIALIT BoneCondenser Tray Aluminum/Stainless Steel/Synthetics

FRIALIT BoneExpander Tray Aluminum/Stainless Steel/Synthetics

FRIALIT Implant Box Aluminum/Stainless Steel/Synthetics

FRIALIT Prosthetic Tray Aluminum/Stainless Steel/Synthetics

FRIALIT Select Tray Aluminum/Stainless Steel/Synthetics

FRIALIT Surgical Tray Aluminum/Stainless Steel/Synthetics

FRIOS®

FRIOS BoneCollector Tray Aluminum/Synthetics

FRIOS MicroSaw Tray Surgical Steel/Synthetics

FRIOS Unit Sterilization Tray Stainless Steel/Synthetics

XiVE®

XiVE BoneCondenser Tray Aluminum/Stainless Steel/Synthetics

XiVE Prosthetic Tray Aluminum/Stainless Steel/Synthetics

XiVE Security Kit Tray Aluminum/Stainless Steel/Synthetics

XiVE Select Try-in Implant Basic Set Tray Aluminum/Silicone/Synthetics

XiVE Surgical Tray Aluminum/Stainless Steel/Synthetics

XiVE Tap Set Tray Aluminum/Stainless Steel/Synthetics

6

List of Medical Products for Sterilization/DisinfectionANKYLOS

®

ANKYLOS Cutting and Abrasive Instruments

ATP Punch Yes1,4 Sterilization Yes Medical Grade Steel

BoneCondenser Yes Sterilization Ti6Al4V

BoneExpander Yes Sterilization Ti6Al4V

Drills, Milling Tools, Conical Reamers Yes1 Sterilization Medical Grade Steel

Implant Recovery Instruments Yes Sterilization Medical Grade Steel

Mucosa Punch Yes4 Sterilization Yes Medical Grade Steel

Sinus Lift Instruments Yes Sterilization Medical Grade Steel

Taps Yes1 Sterilization Medical Grade Steel

ANKYLOS Surgical Components

Assembly Device for Implants Yes Sterilization Titanium

Direction Gauges Surgery Yes Sterilization Synthetics

Extra Long Instruments Yes Sterilization Medical Grade Steel

Parallel Gauges for Drills Yes Sterilization Titanium

Surgical Mallet and Chisel Yes2 Sterilization Medical Grade Steel

Trial Abutments Yes Sterilization Synthetics

Tweezers Yes Sterilization Titanium

ANKYLOS Ratchets, Torque Drivers, Activators, De-activators

Activator/De-activator for Matrix of Snap Attachment Yes Sterilization Med. Grade Steel/Synthetics

Assembly Device Yes Sterilization Stainless Steel

Cover Cap for Ratchet Insert Yes Sterilization Medical Grade Steel

Handles Yes Sterilization Medical Grade Steel

Insertion Instruments for Implants Yes Sterilization Medical Grade Steel

Inserts for Prosthetic Ratchet Yes Sterilization Yes Medical Grade Steel

Mounting Device Insert for Prosthetic Ratchet Yes Sterilization Medical Grade Steel

Open-end Wrench Yes Sterilization Medical Grade Steel

Placement Aids Yes Sterilization Medical Grade Steel

Prosthetic Ratchet Yes Sterilization Yes Medical Grade Steel

Re-Usability Sterilization/ Disassembly MaterialDisinfection

1 All cutting or abrasive products must be replaced after 20 uses or as use demands (e.g. due to bluntness).2 Resharpen if blunt.3 Final product can be sterilized (after casting).4 Disposable product (mucosa punch, center pin).

7

Ratchet Inserts for Implants Yes Sterilization Medical Grade Steel

Ratchet Inserts for Instruments Yes Sterilization Medical Grade Steel

Screwdriver Inserts Yes Sterilization Medical Grade Steel

Surgical Ratchet Yes Sterilization Yes Medical Grade Steel

Unscrew Instruments for Cover Screws Yes Sterilization Medical Grade Steel

ANKYLOS ® Screws/Sleeves

Screws No Sterilization Ti6Al4V

Sleeves/Threaded Sleeves No Sterilization Permador® PDF

ANKYLOS Impression Taking/Abutments

Balance Base Abutments No Sterilization Ti6Al4V

Balance Posterior/Anterior Abutments No Sterilization Ti6Al4V

Drilling Sleeve for SynCone® No Sterilization Ti6Al4V

Gold Copings/Bars (Standard Abutment) No Sterilization DEGUNORM/Permador

Gold Coping DEGUNORM® No Sterilization DEGUNORM

Gold Coping Permador/Permador PDF No Sterilization Permador/Permador PDF

Parallel Gauge Yes Sterilization Ti6Al4V

Positioning/Polymerisation Sleeve No Sterilization Synthetics

Retention Copings No Sterilization Ti6Al4V

Standard Abutments (All) No Sterilization Ti6Al4V

Standard Abutments with Snap Attachment No Sterilization Ti6Al4V/Permador

Sulcus Former No Sterilization Ti6Al4V

SynCone Abutment No Sterilization Ti6Al4V

Taper Cap for SynCone No Sterilization Degulor® 3406

Temporary Caps No Disinfection Synthetics

Transfer Cap No Disinfection Synthetics

Transfer Components for the Balance System No Sterilization Medical Grade Steel

Wax-Up Copings No Sterilization3 Synthetics


ADDITIONAL NOTES:

All materials qualify for medical use. Please contact DENTSPLY Friadent at

[email protected] for more detailed specifications.

8

List of Medical Products for Sterilization/Disinfection

FRIALIT®

/XiVE®

and FRIADENT®

FRIALIT/XIVE, and FRIADENT Cutting and Abrasive Instruments

Drills, Stepped Drills, Depth Stops, and Fitting Tools Yes1 Sterilization Yes Medical Grade Steel

FRIADENT BoneProfiler Yes1 Sterilization Medical Grade Steel

FRIADENT Periotome/Periotome Blades Yes/Yes1 Sterilization Yes Medical Grade Steel

FRIADENT Tissue Punch Yes1 Sterilization Medical Grade Steel

FRIALIT/XiVE BoneCondenser Yes1 Sterilization Med. Grade Steel/Synthetics

FRIALIT/XiVE BoneExpander Yes Sterilization Med. Grade Steel/Synthetics

FRIADENT Trephine Drills Yes1 Sterilization Medical Grade Steel

XiVE Taps Yes1 Sterilization Ti6Al4V

FRIALIT/XiVE, and FRIADENT Surgical Components

FRIADENT Depth Gauges, Gingiva Measuring Devices Yes Sterilization Titanium

FRIADENT Drill Extensions Yes Sterilization Medical Grade Steel

FRIADENT Implant Forceps Yes Sterilization Titanium

FRIADENT Implant Mallet Yes Sterilization Med. Grade Steel/Synthetics

FRIADENT Radiographic Balls Yes Sterilization Medical Grade Steel

FRIADENT Seating Instruments, Paralleling Pins Yes Sterilization Titanium

FRIALIT/XIVE, FRIADENT Select Components Yes Sterilization Titanium

FRIALIT/XiVE, and FRIADENT Ratchets, Screwdrivers, Implant Drivers, Activators, Deactivators

FRIADENT Activator/Deactivator for Attachments Yes Sterilization Med. Grade Steel/Synthetics

FRIADENT Bar Clip Activator Yes Sterilization Medical Grade Steel

FRIADENT Drivers (Handpiece/Ratchet) Yes Sterilization Medical Grade Steel

FRIADENT Ratchet Yes Sterilization Yes Medical Grade Steel

FRIADENT Ratchet Inserts Yes Sterilization Medical Grade Steel

FRIADENT Seating Instruments Yes Sterilization Titanium

FRIADENT Torque Drivers Yes Sterilization Yes Medical Grade Steel

FRIALIT/XiVE, FRIADENT Implant Drivers Yes Sterilization Medical Grade Steel

FRIALIT/XiVE, FRIADENT Screws/Sleeves

FRIADENT Cover Screws/MP Cover Screws No Sterilization Titanium

FRIADENT Fixation Screws No Sterilization Ti6Al4V

FRIADENT Standard Abutment Screws No Sterilization Ti6Al4V



ADDITIONAL NOTES:



9

FRIADENT® Thread Sleeves No Sterilization High-Nobel Alloy

FRIADENT Transfer Screws No Sterilization Ti6Al4V

XiVE® TG Abutment Screws No Sterilization Ti6Al4V

XiVE TG Coping Screws No Sterilization Ti6Al4V

XiVE TG Cover Screws for Implants No Sterilization Titanium

XiVE TG PickUp Guide Pins No Sterilization Ti6Al4V

FRIALIT/XiVE, FRIADENT Impression Taking, Abutments

FRIADENT CeraBase No Sterilization Al2O3/Ti6Al4V/Titanium

FRIADENT EstheticBase No Sterilization Ti6Al4V/Titanium

FRIADENT AuroBase No Sterilization3 High-Nobel Alloy/Synthetics

FRIADENT EstheticCap No Sterilization Synthetics

FRIADENT Gingiva Formers (All) No Sterilization Titanium

FRIADENT Gold Round Bars No Sterilization High-Nobel Alloy

FRIADENT MP Abutments No Sterilization Ti6Al4V/Titanium

FRIADENT MP Classic Abutments No Sterilization Ti6Al4V/Titanium

FRIADENT ProTect No Disinfection Synthetics

FRIADENT Telescopic Abutments No Sterilization Ti6Al4V/Titanium

FRIADENT TempBase No Sterilization Ti6Al4V

FRIADENT TempBase Cap No Disinfection Synthetics

FRIADENT Titanium Round Bars No Sterilization Titanium

FRIADENT TransferCap No Disinfection Synthetics

FRIADENT Transfer Coping Basic No Sterilization Titanium

FRIADENT Transfer Copings No Sterilization Titanium

FRIADENT, XiVE TG Attachment No Sterilization Ti6Al4V/High-Nobel Alloy

FRIADENT, XiVE TG AuroBase No Sterilization3 High-Nobel Alloy/Synthetics

FRIADENT, XiVE TG Castable Waxing Sleeves No Sterilization3 Synthetics

FRIADENT, XiVE TG Cast-to Waxing Sleeves No Sterilization3 HSL/Synthetics

FRIADENT, XiVE TG Gold Bar Copings No Sterilization High-Nobel Alloy

FRIADENT, XiVE TG Impression Copings No Sterilization Titanium

FRIADENT, XiVE TG Titanium Bar Copings No Sterilization Titanium

XiVE TG Abutments No Sterilization Titanium


10

List of Medical Products for Sterilization/DisinfectionFRIOS

®


FRIOS BoneCollector (Case) Yes Sterilization Yes Titanium

FRIOS BoneShield Form Set Yes Sterilization Titanium/Synthetics

FRIOS MicroSaw Chisel Yes2 Sterilization Medical Grade Steel

FRIOS MicroSaw (Protector) Yes Sterilization Medical Grade Steel

FRIOS Trephines for Bone Removal Yes1 Sterilization Medical Grade Steel

Trephine Drill Yes1 Sterilization Medical Grade Steel


ADDITIONAL NOTES:



11

Disassembly/Assembly of DENTSPLY FriadentCeraMed Medical Products

ANKYLOS® Surgical RatchetDisassembly

• Twist the directional knob at the end of the Ratchet to ensure the drive is engaged.• Press direction knob down while rotating it slowly counter-clockwise. A slight click

or change in rotational resistance is felt. Pull directional knob away from Surgical Ratchet (1).

• Unscrew the Knurled Handle (2).• Remove the return spring and the central direction shaft from the Surgical Ratchet body.• Prepare disassembled components per direction on page 3 procedures 2-4.• Prior to assembly and sterilization, cover the components with a thin layer of resin-free

oil and let excess oil drip off.

Assembly

• Assemble instruments in reverse order and sterilize as described on page 3 procedures 5-7.

ANKYLOS Prosthetic Ratchet/FRIADENT® RatchetDisassembly

• Unscrew the head of the Prosthetic Ratchet (1) from the Ratchet’s body (5).• While holding the Ratchet head, remove inner mechanics.• Disassemble the guide jacket (2), sprocket (3), and ratchet spring (4).• Prepare disassembled components per direction on page 3 procedures 2-4.• Prior to assembly and sterilization, cover the components with a thin layer of resin-free

oil and let excess oil drip off.

Assembly

• Assemble instruments in reverse order and sterilize as described on page 3, procedures 5-7.

ANKYLOS/FRIADENT Torque Driver Inserts for Prosthetic RatchetDisassembly

• Using the nipple at the end of the Prosthetic Ratchet, align with the recess of the torque drivers and push together. This action will disengage inner mechanics from the outer case of torque driver.

• Prepare disassembled components per direction on page 3 procedures 2-4.

Assembly

• Insert the torque driver’s inner mechanics to outer case(when assembling an ANKYLOS 1mm or 1.8mm hex torque driver instrument, first engage the hex drive into the Fitting Aid for Prosthetic Ratchet Inserts).

• Holding the torque driver, rotate the outer case clockwise while pushing both parts together until they lock (click).

• Sterilize assembled instruments as described on page 3 procedures 5-7.

2

1

3

1 2 3 4 5

12


1

2

3

4

IMPORTANT!The sleeve (4) for the ATP Punch is disposable and must be replaced after use.

IMPORTANT!The center pin and the punching canula are disposable and must be replaced.

1

32

4

5

ANKYLOS® ATP Punch

Disassembly

• The ATP Punch is held together by a bayonet fitting and can be disassembled by twisting.

• Hold the case of the ATP Punch and turn the milling tool (1) clockwise.

• Remove case (2) and spring (3) from the milling tool.• The sleeve for the ATP Punch (4) can be slid from the milling tool. • Prepare disassembled components per direction on page 3

procedures 2-4.• Replace sleeve with new.

Assembly

• Slide the sleeve for the ATP Punch on the milling tool.• Turn the sleeve and milling tool clockwise.• Insert the spring and case on the milling tool.• Turn case and milling tool clockwise.• Sterilize prior to use as described on page 3 procedures 5 -7.

ANKYLOS Mucosa PunchDisassembly

• Loosen the cover screw with the screwdriver counter-clockwise from the large milled ring nut (1/2).

• Remove the center pin with the spring (3).• Loosen the small milled ring nut by turning it counter-clockwise.• Remove the punching canula from the clamping chuck.• Prepare disassembled components per direction on page 3 procedures 2-4.• Replace center pin and Punching Canula with new.

Assembly

• Assemble in reverse order.• Sterilize prior to use as described on page 3 procedures 5-7.

Changing the Length of the Mucosa Punch

• Turn the cover screw on the large milled ring nut with the screwdriver of the mucosa punch.

• When removing the screw, mind the compression spring of the punch (spring load!).

• Remove the center pin with the compression spring, insert the compression spring on the required length of the center pin, and insert it back into the mucosa punch (be aware of the pinpoint).

• When screwing in the cover screw avoid pinching the compression spring.

Changing the Punching Cylinder

• Turn the small milled ring nut against the large one and unscrew it.• Remove the punching canula from the chuck and turn or replace it (5).• Please pay attention to the pinpoint when inserting the punching canula.

13

FRIALIT® Drill DepthStop ToolDisassembly

• Place the shaft end of the drilling instrument on a soft pad (1/2).• Remove the depth stop tool from the drilling instrument with the long-fitting aid.• Prepare disassembled components per direction on page 3 procedures 2-4.

Assembly

• Assemble the depth stop tool with the short-fitting aid on the drilling instrument.• Sterilize prior to use as described on page 3 procedures 5 -7.

IMPORTANT!

• The depth stop tools of the FRIALIT® Drills 2.0, 3.4 & 3.8 are not pre-assembled.• The depth stop tools of the FRIALIT® Drills 4.5, 5.5 & 6.5 are pre-assembled.

XiVE® Drive Stops for Twist DrillsDisassembly

• Place the tip of the drilling instrument on a soft pad (e.g. OR-Sheet).• Remove the depth stop manually over the tip of the drilling instrument.• Prepare disassembled components per direction on page 3 procedures 2-4.

Assembly

• Push the depth stop manually over the tip of the drilling instrument.• Sterilize prior to use as described on page 3 procedures 5 -7.

IMPORTANT!The depth stops for XiVE® Twist Drills are not pre-assembled.

FRIADENT® PeriotomeDisassembly

• Loosen the head of the instrument counter-clockwise from the handle.• Remove the blade.• Prepare disassembled components per direction on page 3 procedures 2-4.

Assembly

• Assemble in reverse order.• Sterilize prior to use as described on page 3 procedures 5 -7.

IMPORTANT!

During assembly, the driving stud of the blade must be inserted in one of thenotches at the working part.

21

3 4

ADDITIONAL NOTES:

The D 2.0 pilot drill placement and removal of depth stops is opposite of above.

14


FRIOS® BoneCollector

Disassembly

• Remove the disposable suction tube (1) from the particulate container (2).• Strip the suction unit adapter (3) from the suction unit.• Unscrew the particulate container from the suction unit (4).• Remove the titanium filter (5) from the suction unit adapter.• Prepare disassembled components per direction on page 3 procedures 2-4.

Assembly

• Assemble in reverse order.• Sterilize prior to use as described on page 3 procedures 5 -7.

1

2

3

4

5

IMPORTANT!

The suction tube and titanium filter have to be disposed after use. The sterile titanium filter and the sterile suction tube are inserted in the BoneCollector caseimmediately prior to use.

15

FRIADENT Class I Medical Devices

In terms of the Directive 93/42/EEC Class I Medical Devices are:– Non-active hand-held surgical and prosthetic instruments for implant placement and

augmentation– Components for impression technique, which do not remain in the patient’s mouth – Non-active components for the planning stage

FRIADENT Class IIa, IIb and III Medical Devices

In terms of the Directive 93/42/EEC Class IIa, IIb, and III Medical Devices are:– Dental Implants, membranes, membrane nails, as well as bone reconstruction materials– Active surgical and prosthetic instruments for implant placement and augmentation– Components for impression technique and prosthetic overdenture, which remain in the

patient’s mouth

Manufacturer:FRIADENT GmbH · P.O. Box 71 01 11 · 68221 Mannheim/GermanyPhone: + 49 621 4302-1288 · Fax: + 49 621 47 13 06E-mail: [email protected] · Internet: http://www.friadent.de

Order No. ML-0624 15Dec05.

Distributor North America: DENTSPLY Friadent CeraMed Lakewood, CO 80228 • (800) 426-7836 • www.dentsplyfc.com

Manufacturer: DENTSPLY Friadent GmbH D-68221 Mannheim/Germany

ankylos frialit/xive frios€¦ · frios® frios bonecollector tray aluminum/synthetics frios...

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