SPI®VARIOecoSCREW-RETAINED RESTORATIONS.Prosthetic procedure

2 © Thommen Medical

1. At a glance

These instructions apply to all VARIOeco Abutments, which are identical in design to the titanium bases for CAD/CAM, including the associated VARIOeco auxiliary parts.

Component Material

Titanium base with hexagon/bridge Pure titanium grade 4

Abutment screw Ti alloy

Burn-out plastic cap POM

Laboratory screw Stainless steel

Laboratory cylindrical pin PTFE

INDICATION

Thommen Medical VARIOeco Abutments are intended to be used in conjunction with Thommen implants and are used to produce crown and bridge restorations in the maxilla and mandible.

RESTRICTIONS FOR USE

See General restrictions for use (Page 7).

STORAGE

VARIOeco burn-out plastic caps must be stored at room temperature and protected from exposure to strong light or high heat.

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CLINICAL USE

The Thommen Medical VARIOeco Set is particularly suitable for screw-reta-ined crown and bridge restorations.The VARIOeco set for crowns is used for screw-retained single crowns and optionally also for cemented crowns and bridges. The VARIOeco set for bridges must be used exclusively for screw-retained bridge restorations. The access to the screw channel must be located occlusally in posterior restora-tions and palatally/lingually in anterior restorations. Implant divergences of up to 30° can be bridged with the VARIOeco set for bridges, subject to the number and position of the implants. If these require-ments are not met, do not proceed with a screw-retained restoration and switch to a cemented construction. The following for screw-retained bridges essentially applies also to screw-retained single-tooth restorations.Before insertion and attachment of the prosthetic components, the implant shoulder and inner configuration must be free of contaminants and over-hanging soft tissue. For permanent insertion, it is essential to use new abutment screws. Torque value for the attachment of the titanium base:· 15 Ncm for PF 3.5· 25 Ncm for PF 4.0–6.0

You can find an overview of all torque values for the attachment of Thommen abutments online at: www.ifu-tm.com/THM61122.

TAKING AN IMPRESSION

Producing a prosthetic restoration with VARIOeco plastic caps requires ta-king an impression at the implant level. Impression copings for open and clo-sed-tray techniques are available as impression copings for conventional im-pression taking. Thommen scan abutments can be used to take digital impressions. These can be used either intraorally or for scanning from the master model.

Information on digital impression taking can be found online at: www.ifu-tm.com/THM61143. Information on conventional impression taking can be found online at: www.ifu-tm.com/THM61127.

MASTER CAST FABRICATION

Implant analogs are available. These can be used for conventional or digital processes. Information on producing digital models can be found online at: www.ifu-tm.com/THM61143.

2. Application and handling

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CONSTRUCTING THE FINAL PROSTHETIC RESTORATION

The final reconstruction must be carried out in accordance with the most up-to-date dental technology in compliance with the manufacturer’s instruc-tions for the materials used.

1. Assembling titanum bases Screw the titanium base for bridges onto the model using abutment

screws.

2. Seating the plastic caps The circular grooves in the screw channel are used to identify the plat-

form. The PF 3.5 has a single groove. Each next-larger platform has an additional groove. Reach the secured position of the plastic cap by rota-ting the titanium base until it engages the rotation lock. Move the cap onto its final position by exerting slight pressure. Using a spacer on the titanium base is not necessary as the cement gap between the burn-out cap and titanium base is included in the design. Burn-out caps are not suitable as a base for producing temporary plastic restorations.

3. Shortening the screw channel Shorten the screw channel according to the opposing occlusion and

abutment design. Ensure sufficient space for veneering.

WAX-UP AND FRAMEWORK CONSTRUCTION

Wax-up the bridge framework on the plastic caps. The outside of the plastic cap must be covered by a minimum wax layer of 0.3 mm. During the wax burn-out, it provides space for the plastic material to swell. If the plastic cap is insufficiently covered by wax, the swelling of the plastic may cause the in-vestment material to fracture and the casting material may fail.

After attaching the sprues and runner bar, unscrew and completely remove all abutment screws.

Remove the wax-up, incl. the titanium base from the analog. During wax-up, the cylindrical pin for laboratory (available for PF 3.5 or PF 4.0–6.0) ensures that no wax residue gets into the screw channel. Remove the cylindrical pins after completing the wax-up.

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The titanium bases must be carefully removed from the wax-up to prevent deformation or stress in the pattern. Laboratory screws PF 3.5 or PF 4.0–6.0 can be used to remove the titanium bases.

Invest and cast the modelled framework as usual.

Fit the cast framework onto the titanium base after divesting in order to achieve passive seating. Take care with the rotation lock for individual tooth restorations.

After adjustment, insert the titanium bases provisionally into the framework construction. Position the framework together with the inserted titanium bases on the analogs in the model using laboratory screws. Check the accuracy of fit of the bridge. If appropriate, readjust the cast framework construction by grinding until a passive fit is achieved.

The bridge framework is then prepared for veneering.

CERAMIC VENEERING

Titanium bases must not be exposed to high temperatures. Titanium bases must be removed from the framework before each veneer firing.

BOND THE TITANIUM BASES WITH THE VENEERED BRIDGE

Blast the surface of the titanium base that is to be bonded with 50 μm alumi-num oxide and at a max. pressure of 2 bar. Cover the collar (A) with a suita-ble material prior to blasting.

Shorten the laboratory cylindrical pin (available separately; Teflon) to the desired length and insert into the titanium base to prevent the adhesive from entering the screw channel. Mix and apply the adhesive (PANAVIA™F 2.0 or ReliyX Unicem™) in accordance with the manufacturer’s instructions. It is imperative that the adhesive remains in a soft state during the following ope-rations:

Working off the model, place each titanium base with inserted cylindrical pin into the corresponding bridge abutment.

6 © Thommen Medical6 © Thommen Medical

Subsequently, align the construction in the analogs on the model. Verify correct and complete seating. Continue by removing the cylindrical pins for laboratory, insert the abutment screws (or laboratory screws) and tighten. Allow the adhesive to cure, remove any remaining adhesive residues and then finish setting the bridge.

PERMANENT ATTACHMENT OF THE FINISHED RESTORATION

Remove the gingiva former or temporary crown(s)/bridge from the implant. Clean and dry the inner configuration of the implant thoroughly before attaching the permanent crown or bridge. Position the crown/bridge on the implant(s), test that its seat is correct and secure final attachment (see Clinical use, Page 3).

After inserting the restoration, refill the screw channel with a removable material (e.g. gutta-percha). Seal the screw channel with a suitable composite material.

CLEANING, DISINFECTION, STERILIZATION

Thommen abutments and components are not supplied in a sterile state. Unless di-rected otherwise, a steam sterilization of the abutment is recommended:· Fractionated vacuum procedure with at least 3 vacuum steps,

(with adequate product drying)· A steam sterilizer compliant with DIN EN 13060/DIN EN 285 and/or

ANSI AAMI ST 79 (for USA: FDA clearance)· Maximum sterilization temperature of 138 °C (280 °F; plus tolerance in compliance with DIN EN ISO 17665)

Sterilization time (exposure time at sterilization temperature) and/or at least 4 minutes (or 18 minutes, prion inactivation – not relevant for USA) at 132 °C (270 °F)/134 °C (273 °F).

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3. General notes

THOMMEN IMPLANT SYSTEM

Manufacturer: Thommen Medical AG Neckarsulmstrasse 28 2540 Grenchen, Switzerland www.thommenmedical.com

Batch code

Use by date

Date of manufacture

Sterilized using irradiation

Sterilized using steam or dry heat

Temperature limitation

Do not re-use

Non-sterile

Caution

Article number

Conformity symbol as specified by EU Directive MDD 93/42/EEC

Consult instructions for use

Do not resterilize

Do not use if package is damaged

Atmospheric pressure limitation

Manufacturer

Keep away from sunlight

May only be sold to and prescribed by physicians (USA)

COLOURED WARNING STICKERApplication has changed - follow the corresponding instruc-tions for use.

New design – the application has not been changed.

PRODUCT INFORMATION The information in this document describes the application of the Thommen Medical implant system. This information is available in electronic form online at: www.ifu-tm.com. For technical advice, the responsible country representative or distributor of Thommen Medical AG is present to answer questions.

COLOR CODE Each implant platform diameter has a color code, which can be found on all implant and abutment packagings, on the impression items and on most diame-ter-specific instruments.

Brown = PF 3.0

Yellow = PF 3.5

Green = PF 4.0

Blue = PF 4.5

Grey = PF 5.0

Purple = PF 6.0

AVAILABILITY Not all of the Thommen Medical products men-tioned in these instructions for use are available in all coun-tries. The responsible country representative or distributor of Thommen Medical AG informs about availability for the coun-try in question.

GENERAL RESTRICTIONS OF USE Restorations with cantilevers to individual implants are not recommended. Indi-vidual restorations with angled abutments should not be used in regions with high mechanical stress. For implants with a small diameter (PF 3.0 and 3.5), the prosthetic restoration should be constructed in such a way that large bending mo-ment does not occur. The Thommen Medical products may not be used on patients who are known to have allergies to the cor-responding materials.

POSSIBLE COMPLICATIONS A stressed loading of the implant or abutment over and above its functional capacity can lead to excessive bone loss or fracture of the implant or restoration. The clinician must supervise the occlusion and functional loading of the prosthetic supraconstruction very carefully.

WARNINGS/PRECAUTIONS All Thommen Medical products that come into effect inside the oral cavity must be protected against aspiration. Thommen Medical products have not been evaluated for safety and compatibility in the MR environment. Thommen Medical products have not been tested for heating, migration, or image artifact in the MR environment. The safety of Thommen Medical products in the MR environment is un-known. Scanning a patient who has this product may result in patient injury.

RESPONSIBILITY/LIABILITY As a part of an overall scheme, Thommen Medical products may be used only with the original components and instruments in accordance with the instruc-tions for use provided by Thommen Medical. The use of non-system parts may compromise the performance of Thom-men Medical products and lead to failures. Users must have appropriate knowledge and information about the handling of Thommen Medical products in order to use the products safely and professionally in accordance with the instructions for use. Thommen Medical products should only be used in accordance with the instructions for use provided by Thommen Medical. The user is obliged to use the Thommen Medical products ac-cording to the instructions for use and to check whether the product is suitable for the individual patient situation. The use of Thommen Medical products is the responsibility of the user, as such, beyond the control of Thommen Medical AG. We re-fuse to accept any responsibility or liability for any damage due to incorrect utilization of the product. Products labeled «Do not re-use» may not be refurbished and/or reused. The refurbish-ment and/or reuse of these products can affect their function (e.g. fitting and/or cutting properties) as well as their safe use (e.g. risk of infection, disease transmission, fading of the lase-

ror color marks, corrosion). Detailed information about the possible consequences, which may result from negligence to follow this information, can be obtained from the responsible country representative or distributor of Thommen Medical AG. Caution: Federal law (USA) restricts this device to sale by or on the order of a dentist or physician. All serious incidents which have occurred in connection with the product must be reported to the manufacturer and the competent authority of the Mem-ber State, in which the user is resident.

GUARANTEE The comprehensive guarantees can be found in the country-specific guarantee leaflets.

TRANSPORT AND STORAGE Please note the specifications on all labels and package leaflets regarding transportation, stor-age and instructions for use. Products whose packaging is damaged must not be used. Under no circumstances may Thommen Medical products be used beyond the expiry date, as proper functioning or sterility of sterile packaged products cannot be guaranteed by the manufacturer anymore.

INSTRUCTIONS FOR USE The following information is not in-tended as comprehensive for the Thommen Implant System. New customers are advised to undergo training by a specialist experienced in the use of this system.

GUARANTEE OF STERILITY Products of the Thommen Implant System supplied in sterile packaging must not be re-sterilized. If the sterile packaging is damaged during transport or stor-age, the product may under no circumstances be used. Prod-ucts that have been opened and have not been immediately used for the intended operation must not be used thereafter. After resterilization, the safety, function and efficacy of the product cannot be guaranteed by the manufacturer. The prod-ucts intended for single use must never be reprocessed, ster-ilized or reused and must be disposed of safely and properly af-ter use in compliance with all applicable legal and regulatory requirements. Reusable products must be reprocessed ac-cording to the instructions for use and, if used on patients, sterilized. They must be checked for their integrity before each use. Any damage (such as scratches, cracks, nicks, notches), as well as bent parts mean that they must not be used any more. The number of reprocessing cycles is limited and must be monitored. If the number of cycles is exceeded, proper func-tion and sterility of the product are not guaranteed by the man-ufacturer anymore.

DISPOSAL In the case of cutting products, there is always a risk of injury, therefore the products must be disposed of safely and properly after use, observing all applicable legal and reg-ulatory requirements. For products and their accessories, which have been used on a patient, there is a risk of a possible infection. Our products are designed and produced so that they can be disposed of safely and correctly after use in compliance with all valid legal and regulatory requirements.

COPYRIGHT©/REGISTERED® SPI®, INICELL® and APLIQUIQ® are registered trademarks of Thommen Medical AG. Publica-tion or reproduction is permitted only with the written consent of Thommen Medical AG. LOCATOR® is a registered trademark of Zest Anchors Inc., CA, USA. Novaloc® is a registered trade-mark of Valoc AG, Rheinfelden, Switzerland. Dynamic Tibase® is a registered trademark of Talladium España S.L., LIeida, Spain.

VALIDITY© Thommen Medical AG. All rights reserved. This in-struction for use replaces all previous editions.

HEADQUARTERS

Thommen Medical AG Neckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 61 965 90 20Fax +41 61 965 90 21info@thommenmedical.com

SUBSIDIARIES/NATIONAL DISTRIBUTORS

AUSTRIAThommen Medical Austria GmbHMühlgasse 32322 Zwölfaxing | AustriaTel. +43 660 2011953info@thommenmedical.at

BENELUXThommen Medical Benelux B.V. Dierenriem 13738 TP Maartensdijk | NetherlandsTel. +31 30 68 68 468Info.benelux@thommenmedical.nl

CHINA Shanghai Yujing Trading Co., Ltd.Room G | Floor 15th | Plaza JiaFa | No.1Lane 129 | DaTian Road | JingAn DistrictShanghai | ChinaTel. +86 21 62723077Fax +86 21 62175264

CZECH REPUBLICC. Witt Dental spol. s r.o.Cihlárská 643/19602 00 BrnoTel. +420 739 043 449helena.novak@cwittdental.cz

FINLAND Vector Laboratories OyEngelinaukio 8 B00150 Helsinki | FinlandTel. +358 400 940 700labs@vektor.fi

FRANCEThommen Medical France10 avenue Gabriel Pierné 77680 Roissy-en-Brie | FranceTel. +33 1 83 64 06 35Fax +33 3 89 33 52 53infos@thommenmedical.fr

GERMANYThommen Medical Deutschland GmbHAm Rathaus 279576 Weil am Rhein | GermanyTel. +49 7621 422 58 30 Fax +49 7621 422 58 41info@thommenmedical.de

HONG KONGShengyuan (Hong Kong) Int. Trade Co. Ltd.Level 13, 68 Yee Wo StreetCauseway Bay | Hong KongTel. +852 530 876 41

ITALYDental Trey S.r.l.Via Partisani, 347016 Fiumana | Predappio (FC) | ItalyTel. +39 0543 929111Fax +39 0543 940659implantologia@dentaltrey.itwww.dentaltrey.it

JAPANJ. Morita Corporation3-33-18, Tarumi-choSuita | Osaka 564-8650 | JapanTel. +81 6 6384 6921Fax +81 6 6384 6746www.morita.com

LITHUANIA/LATVIACERNIKIS MEDICAL PROJECTS, UABSiaures prospektas 5B, KaunasLithuania LT-49191Tel. +370 37 201072Mobile +370 65 771550info@cmp.ltwww.cmp.lt

MIDDLE EASTStar Science International GmbHJupiterstrasse 573015 Bern | SwitzerlandTel. +41 31 941 07 31Fax +41 31 941 07 33star.science@bluewin.ch

NORWAYNovus Dental ASJohannes Bruns gate 50452 Oslo | NorwayTel. +47 951 07 007post@novusdental.nowww.novusdental.no

POLANDC.WITT DENTAL Sp. z o. o.Ul. Granitowa 1087-100 Toruń | NIP 951-15-08-371 | PolandTel. +48 56 623 61 23biuro@cwittdental.plwww.cwittdental.pl

REPUBLIC OF CROATIA Futura Dental d.o.o.Kralja Zvonimira 10810 000 Zagreb | Republic of CroatiaTel. +385 91 6814 860info@futura-dental.hrwww.futura-dental.hr

RUSSIAN FEDERATIONCIS – JSC GeosoftBuild. 14, Ap. 16, 3-ya Mytishchinskaya ul.Moscow, 129626 | Russian FederationTel. +7 495 663 22 11thommenmedical@geosoft.ru

SINGAPOREFONDACO Pte Ltd7 Kaki Bukit Road 1, #03-06Eunos Techno LinkSingapore 415937 | SingaporeTel. +65 6392 2806Fax +65 6392 1296fondaco@fondacosg.com

SOUTH KOREAAPS Advanced Prosthetic Solution201, Kolon Aston505-14 Gasan-dong Geumchoen-guSeoul | South KoreaTel. +82 2 3141 2875Fax +82 2 3141 2877www.apsdd.com

SPAIN/PORTUGALThommen Medical IbéricaC/Los quintos n 103350 Cox (Alicante) | SpainTel. +34 96 536 1020Mobile +34 606 99 78 34info@thommeniberica.com

SWITZERLANDThommen Medical AGNeckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 32 644 30 20Fax +41 32 644 30 25info@thommenmedical.ch

TAIWANEn-Jye International Co., Ltd.No. 18 | Lane 177 | Sec 3 | Chengde Rd.Taipei, 103 TaiwanTel. +886 2 2585 1669Fax +886 2 2585 0892enjye168@gmail.com

TURKEY Bioport Biyolojik Maddeler A.S.Büyükdere cd. Subay evleri 9. Blok D1 EsentepeSisli 34394 Istanbul | TurkeyTel. +90 212 2727577Fax +90 212 2727628info@bioport.com.trwww.bioport.com.tr

USA/CANADAThommen Medical USA L.L.C.1375 Euclid Avenue | Suite 450Cleveland OH 44115 | USATel. +1 866 319 9800 (toll free)Fax +1 216 583 9801info.us@thommenmedical.com orders.us@thommenmedical.com

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