cemented restorations

SPI®EASYCEMENTED RESTORATIONS.Prosthetic procedure

2 © Thommen Medical

1. At a glance

These instructions apply to all EASY abutments, including the EASY e.p. and EASY auxiliary parts, as listed in the product catalogue (www.ifu-tm.com/THM31111). There, you will also find directions on the identifying characteri-stics (geometries, dimensions) of the individual components.

Component Material

EASY abutment, EASY abutment e.p. Pure titanium grade 4

Abutment screw Ti alloy

EASY impression coping POM

EASY temporary cap PMMA-based plastic

EASY analog Stainless steel

EASY burn-out cap, for crowns and bridges POM

INDICATION

Thommen Medical EASY Abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.

RESTRICTIONS FOR USE

In general, a maximum abutment angulation of 20° should not be exceeded.See general restrictions of use (page 7).

STORAGE

EASY impression coping and temporary caps must be stored at room tempe-rature and protected from exposure to strong light or high heat.

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2,3 mm 1,9 mm

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CLINICAL USE

The Thommen Medical EASY abutments are particularly suitable for cemen-ted crown and bridge restorations.

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 EASY abutment:· 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.

ABUTMENT LEVEL IMPRESSION

Abutment level impression requires:1. Unmodified abutment2. Permanent insertion of the abutment (see clinical use)3. Corresponding impression copings

The impression must be carried out using a closed-tray technique and an elastomer impression material (no hydrocolloids).

The cone height of the abutment (4.0 or 6.0 mm) is specified on top of the impression coping.

The anti-rotation surface of the impression coping must align with the anti-rotation surface of its EASY abutment counterpart.

Press the impression coping onto the abutment until the snap mechanism engages. Once the impression has been taken, a temporary restoration can be fabricated using the EASY temporary cap (page 4).

IMPLANT LEVEL IMPRESSION

If the EASY abutment is modified, the impression must be taken on the implant level. Different impression copings are available for taking the impression on the implant level using the open- or closed-tray technique (see product catalogue). In this case, temporary restorations are fabricated using customizable gingiva formers or temporary abutments.

For more information about impression techniques please refer to www.ifu-tm.com/THM61127

2. Application and handling


2.3 mm 1.9 mm

MODIFYING THE ABUTMENT

EASY abutments can be shortened to the minimal height of 2.3 mm (PF B

4.0–6.0 mm) or 1.9 mm (PF B 3.5 mm) according to need.

Moreover, using EASY abutments with collar height long, extra-long or EASY abutments e.p., the crown margin can be adapted individually to match the gingival profile.

The minimal wall thickness after contour shaping must not be less than 0.5 mm. A minimal collar height of 0.5 mm must be maintained.

FABRICATING THE LABORATORY MODEL

Various abutment and implant analogs are available for fabricating the laboratory model, according to standard procedure. All model analogs are intended for single use. EASY abutment analogs are required when taking the impression on the abutment level.

FABRICATING THE TEMPORARY RESTORATION CHAIRSIDE

A circular marking on the outside of the temporary cap facilitates the identi-fication of the anti-rotation surface: the marking is positioned opposite the anti-rotation surface.

When fabricating a bridge, the safety lock can be eliminated by removing the snap mechanism. If the abutment is modified, the EASY temporary cap must also be modified accordingly. Clean the cone of the EASY Abutment thoroughly and seal the screw channel with a removable material before cementing the EASY temporary cap. Fix the EASY temporary cap on the EASY Abutment using temporary cement. The temporary restoration must be out of occlu-sion.

If an EASY temporary cap is to be veneered to look like a tooth, then all current fabrication methods can be used. For chemical bonding to the EASY temporary cap, a two-component PMMA-based veneer resin must be used following the manufacturer’s instructions.

Alternatively, the temporary restoration can be fabricated on the laboratory model by the dental technician.


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.

Place the EASY plastic burn-out cap on the EASY analog. Allow the snap mechanism to engage in the inner cone. (For modified abutments, the framework modelling is carried out after application of a “cement spacer” and wax insulation directly on the abutment, without a plastic burn-out cap).

WAX-UP AND FRAMEWORK CONSTRUCTION

The outside of the plastic burn-out cap must be covered with a wax layer of at least 0.2 mm (see red line).

The wax layer added during the pattern fabrication provides the necessary expansion zone for the plastic pattern during burn-out. Insufficient coverage of the EASY burn-out cap with wax can cause the investment mold to frac-ture due to the expansion of the plastic material, which may result in casting failure.

The delicate marginal area must not be covered with wax.

A sufficiently thick layer of wax must be applied if a framework is fabricated without a plastic burn-out cap.

Finish fabricating the framework and attach casting sprues to the pattern. Carefully remove the fabricated framework from the EASY Abutment. The in-vestment mold material needs to be matched with the alloy used (preferably with a high gold content).

To help ensure a successful casting, a stepped (multi-state) burn-out is recommended when using plastic burn-out caps.

VENEERING THE FRAMEWORK

The snap mechanism (now cast in alloy) must be removed prior to placing the cast cap on the abutment analog or original abutment. The internal configu-ration of the casting should not be sandblasted. Veneer in accordance with normal procedures.


PERMANENT ATTACHMENT OF THE FINISHED RESTORATION WITHOUT ABUTMENT MODIFICATION

Remove the temporary cap on the EASY abutment, completely remove any remaining cement and clean the cone of the EASY abutment thoroughly. Seal the screw channel of the EASY abutment with a removable material (teflon, gutta percha, light body impression material, etc.) and fix the suprastructure on the EASY abutment using a commercially available cement.

PERMANENT ATTACHMENT OF THE FINISHED RESTORATION WITH ABUTMENT MODIFICATION

The procedure with a modified EASY abutment requires taking an impression on the im-plant level. The temporary restoration is removed completely from the implant before insertion of the modified EASY abutment. Fix the EASY abutment on the implant using a new abutment screw (“Clinical use”, page 3). Subsequently, seal the screw channel as described above.

The suprastructure is then fixed on the EASY abutment using a commercially available cement.

CLEANING, DISINFECTION, STERILIZATION

Thommen abutments and components are not supplied in a sterile state. Unless directed 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) of at least 4 minutes (or 18 minutes, prion inactivation – not relevant for USA) at 132 °C–134 °C (270 °F–273 °F). EASY impression copings, protective caps and temporary caps are intended for single use and must not be sterilized. They can be disinfected using 30% alcohol solution, if required. The alcohol must be allowed to evaporate completely prior to any further processing.


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 [email protected]

SUBSIDIARIES/NATIONAL DISTRIBUTORS

AUSTRALIA/NEW ZEALANDOsteon Medical23/1866 Princess HighwayClayton Victoria 3168 | AustraliaTel. (inside Australia): 1300 411 473Tel. (outside Australia): +61 3 9264 [email protected]

AUSTRIAThommen Medical Austria GmbHMühlgasse 32322 Zwölfaxing | AustriaTel. +43 660 [email protected]

BENELUXThommen Medical Benelux B.V. Dierenriem 13738 TP Maartensdijk | NetherlandsTel. +31 30 68 68 [email protected]

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 [email protected]

FRANCEThommen Medical France10 avenue Gabriel Pierné 77680 Roissy-en-Brie | FranceTel. +33 1 83 64 06 35Fax +33 3 89 33 52 [email protected]

GERMANYThommen Medical Deutschland GmbHAm Rathaus 279576 Weil am Rhein | GermanyTel. +49 7621 422 58 30 Fax +49 7621 422 58 [email protected]

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 [email protected]

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 [email protected]

MIDDLE EASTStar Science International GmbHJupiterstrasse 573015 Bern | SwitzerlandTel. +41 31 941 07 31Fax +41 31 941 07 [email protected]

NORWAYNovus Dental ASJohannes Bruns gate 50452 Oslo | NorwayTel. +47 951 07 [email protected]

POLANDC.WITT DENTAL Sp. z o. o.Ul. Granitowa 1087-100 Toruń | NIP 951-15-08-371 | PolandTel. +48 56 623 61 [email protected]

REPUBLIC OF CROATIA Futura Dental d.o.o.Kralja Zvonimira 10810 000 Zagreb | Republic of CroatiaTel. +385 91 6814 [email protected]

RUSSIAN FEDERATIONCIS – JSC GeosoftBuild. 14, Ap. 16, 3-ya Mytishchinskaya ul.Moscow, 129626 | Russian FederationTel. +7 495 663 22 [email protected]

SINGAPOREFONDACO Pte Ltd7 Kaki Bukit Road 1, #03-06Eunos Techno LinkSingapore 415937 | SingaporeTel. +65 6392 2806Fax +65 6392 [email protected]

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 [email protected]

SWITZERLANDThommen Medical AGNeckarsulmstrasse 282540 Grenchen | SwitzerlandTel. +41 32 644 30 20Fax +41 32 644 30 [email protected]

TAIWANEn-Jye International Co., Ltd.No. 18 | Lane 177 | Sec 3 | Chengde Rd.Taipei, 103 TaiwanTel. +886 2 2585 1669Fax +886 2 2585 [email protected]

TURKEY Bioport Biyolojik Maddeler A.S.Büyükdere cd. Subay evleri 9. Blok D1 EsentepeSisli 34394 Istanbul | TurkeyTel. +90 212 2727577Fax +90 212 [email protected]

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 [email protected] [email protected]

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cemented restorations

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