CUSTOMIZABLE GINGIVA FORMER.FOR SOFT TISSUE MANAGEMENT.Prosthetic procedure

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1. At a glance

These instructions apply to the customizable gingiva former and associated customizable gingiva former auxiliary parts, as listed in the product catalogue (www.ifu-tm.com/THM31111). There, you will also find directions on the iden-tifying characteristics (geometries, dimensions) of the individual components.

Component Material

Gingiva former Pure titanium grade 4/PMMA-based plastic

Fabrication screw Stainless steel

INDICATION The customizable gingiva former is indicated for the shaping of soft tissue and/or the temporary restoration of single-tooth crowns on implants.

RESTRICTIONS FOR USE

Customizable gingiva formers are designed for use with single teeth only. Since axial divergences cannot be bridged, the customizable gingiva former must not be used in conjunction with other abutments.

The customizable gingiva former may remain in the mouth for a maximum of 30 days.

STORAGE

The customizable gingiva former must be protected from exposure to strong light or high heat.

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CLINICAL USE

There are various options available for the use of the customizable gingiva former:· as a gingiva former, shortened to gingival level· as a provisional abutment for the fabrication of a cement-retained,

single-tooth temporary restoration· as a directly veneered screw-retained single-tooth temporary restoration

Before insertion and attachment of the prosthetic components, the implant shoulder and inner configuration must be free of contaminants and overhan-ging soft tissue.

For permanent insertion, it is essential to use new abutment screws.Torque value for the attachment of the customizable gingiva former:Tightening torque immediately after implantation· 10 Ncm

Tightening torque after successful osseointegration· 15 Ncm for PF B 3.5 mm· 25 Ncm for PF B 4.0–6.0 mm

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

2. Application and handling

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MODIFICATION OF THE GINGIVA FORMER

The customizable gingiva former can be shortened to a minimal height of 2.7 mm (PF B 4.0–6.0 mm) or 2.3 mm (PF B 3.5 mm).

Shaping by reductionIt is recommended to perform the majority of the grinding outside the mouth. A circular plastic element must be left in place in order to ensure that the preinstalled plastic remains stable on the abutment. The custo-mizable gingiva former must be out of occlusion. For safe processing and for the protection of the implant abutment connection, the gingiva former should always be fixed on the analog.

Shaping by additionA PMMA-based plastic veneer must be used for processing (following the manufacturer’s instructions). The chemical bond formed with PMMA- based plastic materials eliminates the need for mechanical retention. The screw channel should be protected during the veneering process. Ideally, this should be carried out with the correct fabrication screw, which can also be used to extend the screw channel of the restoration. The fabrication screw is available in two sizes: for PF B 3.5 mm and PF B 4.0–6.0 mm. Ti-ghten only by hand using a maximum torque of 5 Ncm.

The fabrication screw is to be used exclusively as a fabrication aid for single use. Do not use the fabrication screw for final placement of the customiz-able gingiva former in the patient. Fabrication screws are not supplied with the customizable gingiva former.

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CLEANING, DISINFECTION, STERILIZATION

The customizable gingiva former must not be subjected to heat sterilization and is to be used exclusively for single use.

A 30% alcohol solution can be used for disinfection according to need. The alcohol must be allowed to evaporate completely before placement in the mouth.

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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 diameter-specific instruments.

brown = PF 3.0

Yellow = PF B 3.5 mm

Green = PF B 4.0 mm

Blue = PF B 4.5 mm

Grey = PF B 5.0 mm

Purple = PF B 6.0 mm

AVAILABILITY Not all of the Thommen Medical products mentioned in these instructions for use are available in all countries. The responsible country representative or distri-butor of Thommen Medical AG informs about availability for the country in question.

GENERAL RESTRICTIONS OF USE Restorations with cantilevers to individual implants are not recommended. In-dividual 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 moment does not occur. The Thommen Medical products may not be used on patients who are known to have allergies to the corresponding 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 envi-ronment. Thommen Medical products have not been tested for heating, migration, or image artifact in the MR environ-ment. The safety of Thommen Medical products in the MR environment is unknown. 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 ori-ginal components and instruments in accordance with the instructions for use provided by Thommen Medical. The use of non-system parts may compromise the performance of Thommen 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 in-structions 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 according 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 refuse to accept any responsibi-lity 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 refurbishment 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 laseror 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.

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, storage 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 pro-ducts cannot be guaranteed by the manufacturer anymore.

INSTRUCTIONS FOR USE The following information is not intended as comprehensive for the Thommen Implant Sys-tem. 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-steri-lized. If the sterile packaging is damaged during transport or storage, the product may under no circumstances be used. Products 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 products intended for single use must never be reprocessed, sterilized or reused and must be dis-posed of safely and properly after use in compliance with all applicable legal and regulatory requirements. Reusable products must be reprocessed according 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 moni-tored. If the number of cycles is exceeded, proper function and sterility of the product are not guaranteed by the manuf-acturer 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 regulatory requirements. Products that have been used on a patient are at risk of infection. After application, they must be disposed of safely and properly in compliance with all applicable legal and regulatory requirements.

COPYRIGHT©/REGISTERED® SPI®, INICELL® and APLIQUIQ® are registered trademarks of Thommen Medical AG. Publi-cation 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 re-gistered trademark of Valoc AG, Möhlin, CH.

VALIDITY © Thommen Medical AG. All rights reserved. This instruction 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

AUSTRALIA/NEW ZEALANDOsteon Medical23/1866 Princess HighwayClayton Victoria 3168 | AustraliaTel. (inside Australia): 1300 411 473Tel. (outside Australia): +61 3 9264 0111info@osteonmedical.comwww.osteonmedical.com

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

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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