Basic information on the Straumann® Variobase™ Abutment. 1 Straumann is the industrial partner of the ITI (International Team for Implantology) in the areas of research, development, and education. Contents. 1.Introduction 1.1 2. 3. 5. 2 General Information 3 2.1 2.2 2.3 2.4 3 3 4 5 Introduction to the Straumann® Variobase™ Abutment Technical requirements System overview Product characteristics Restoration, design and finishing 3.1 3.1.1 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.3 3.4 4. Purpose of this guide 2 Preparation Fabrication of the master cast Design and fabrication of a coping/crown Scanning and designing with a scanbody Scanning and designing with a wax-up Milling Finishing of the coping/crown in dental laboratory Bonding Insertion (dentist’s office) 6 6 6 7 7 8 9 10 10 12 Auxiliaries and instruments 13 4.1 4.2 4.3 13 13 13 SCS Screwdrivers Ratchet Polishing aids and analog holder Important guidelines 14 1 1. Introduction. 1.1 Purpose of this guide This guide was created for dental technicians and dentists working with the Straumann® Variobase™ Abutment for designing screw-retained or cement-retained customized abutments and cement-retained bridges (via mesostructure). It provides step-by-step information on working with the Straumann Variobase Abutment. Warning/Pre-Caution Failure to follow the procedures outlined in these instructions may harm the patient and/or lead to any or all of the following complications: • Aspiration or swallowing of a component • Breakage • Infection Note Implant-borne superstructures require optimal oral hygiene on the part of the patient. This must be considered by all involved parties when planning and designing the restoration. Consult the brochure Basic Information on the Surgical Procedures – Straumann Dental Implant System for information on indications and contraindications of Straumann implants, such as the required minimum number of implants, implant type, diameter and loading protocols. 2 2. General information. 2.1 Introduction to the Straumann® Variobase™ Abutment The Straumann Variobase Abutment provides dental laboratories with the flexibility to create customized abutments through their preferred workflow. In addition, the Straumann Variobase Abutment comes with the benefit of the original Straumann connection and the unique Straumann engaging mechanism. For intended use and indications for use, please refer to the instructions for use. 2.2Technical requirements for digital workflow Straumann Variobase Implant Kit To facilitate the precise design of the interface between the Straumann Variobase Abutment and the coping, a specific digital Straumann Variobase Implant Kit is required with your software platform. The kit consists of an open STL file containing the required coping geometry. The Straumann Variobase Implant Kit is available from Straumann on request. Note The Straumann Variobase Implant Kit only provides the geometry of the coping for the Straumann ­Variobase Abutment. Software To design using the Straumann Variobase Abutment for digital workflows, CAD software containing the Straumann Variobase Implant kit can be used. Please follow the instructions of the CAD software provider. Please contact Straumann for more information regarding availability. Milling Once the coping is designed using CAD software, the resulting STL file is sent to Straumann. Milling is available for customers with the Straumann CS2 scanner or the CARES® prosthetic app for Dental Wings scanners. 3 2.3System overview The Straumann® Variobase™ Abutment covers the following Straumann implant platforms. NC RC NNC RN WN 025.2101 025.4101 048.127 048.124 048.124 025.2915 025.4915 048.173 048.168 048.169 025.2921 025.4921 048.709 048.710 048.711 023.2756/ 023.2756-041 023.4759/ 023.4759-041 048.267/ 048.267V41 048.268/ 048.268V41 048.269/ 048.269V41 025.2900 025.4900 048.313 048.356 048.356 Analogs Scanbodies Variobase Abutments Burn-out copings Auxiliary screws 1 Article numbers ending in V4 or in -04 contain 4 burn-out copings in one pack. 4 2.4 Product characteristics Reliability • The original Straumann® implant-abutment connection • Strong retention of the coping with a patented 2 engaging mechanism • Extra bonding surface with 4 cams Efficiency • Variobase™ STL data available for various CAD software platforms • Easy and precise wax-up process with accurate burn-out copings • Compact base dimensions for design flexibility • Simplified bonding process • Skip the sandblasting process • 4 cams facilitate precise positioning of the coping Cost-effectiveness • Use the CAD software of choice, and send to Straumann 2 Patent pending. 5 3. Restoration, design and finishing. 3.1Preparation Prerequisites • The tooth shade has been identified • The impression has been taken • Shade information and impression have been sent to the dental lab 3.1.1Fabrication of the master cast To ensure high-quality restorations, fabricate the master cast using standard methods and type-4 dental stone (ISO 6873). Adhere to the following requirements: • Use new, undamaged and original Straumann implant analogs • Embed the implant analogs in the stone; the analogs must not move in the model • Always use a gingival mask to ensure the emergence profile is optimally contoured • Use scannable material for the gingival mask 6 3.2Design and fabrication of coping/crown 3.2.1SCanning and designing with a scanbody Step 1 – Assembling Check for proper fit of the scanbody in the analog and hand-tighten the self-retaining screw (maximum 15 Ncm). Use the Straumann® SCS Screwdriver to fix the post in the analog. Check again for proper fit and for any rotational or vertical looseness. If a single-tooth restoration is planned, orient the angled surface of the scanbody buccally (not adjacent to the approximal tooth). Avoid any contact of the scanbody to the proximal teeth. Step 2 – Scanning and modeling Follow the software provider’s instructions on how to scan and recognize the scanbody. Design the coping or crown following the software provider’s instructions. 7 3.2.2SCANNING AND DESIGNING WITH A WAX-UP Step 1 – Placing of the Straumann® Variobase™ Abutment Place the Straumann Variobase Abutment on the analog and handtighten the screw (maximum 15 Ncm). Use the Straumann SCS Screwdriver to place the abutment on the analog. Check again for proper fit and for any rotational or vertical movement. Step 2 – Assembly of the burn-out coping Attach the burn-out coping to the Straumann Variobase Abutment and check for proper fit. Note Working with the burn-out coping supports a clean and sharpedged finish of the screw channel and a good fit to the S ­ traumann Variobase Abutment. Note The burn-out coping should be free of any rotational or vertical movement. Step 3 – Shortening of the burn-out coping Shorten the burn-out coping to the height of the occlusal plane according to the individual circumstances. Note Ensure that the shortened burn-out coping still covers the Straumann Variobase Abutment completely. 8 Step 4 – Wax-up Contour a wax-up according to the individual anatomical situation. Note • Make a reduced anatomic design or a full-contour design depending on the indications of the dental material used • Ensure that the wax layer on the abutment is sufficiently thick • Respect the minimal wall thickness of the respective dental material used according to the manufacturer’s instructions Step 5 – Scanning and Modeling Follow the software provider's instructions on how to scan and recognize the wax-up. Complete design of the coping following the software provides instructions. 3.2.3Milling Preparation for milling Transfer design data to Straumann by following the instructions of your CAD software provider. Note • Use the proper settings per material following the instructions of your CAD software provider • In lab milling or third party milling is not indicated and will void the warranty 9 3.2.4FINISHING of the coping/crown in dental laboratory Step 1 – Finishing of the coping/crown Use standard procedures to finalize the coping or crown. Note • The coping or crown to be bonded to the Straumann® Variobase™ Abutment must be finalized before bonding • For cement-retained restorations, the crown can be made and finalized after the bonding step 3.3Bonding Step 1 – Seating on master model Seat the Straumann Variobase Abutment on the implant analog in the master model with a screw (hand-tight). Seal the screw channel with wax to prevent excess cement from flowing into the screw channel. Note Due to its patented* engaging mechanism, it is not necessary to sandblast the Straumann Variobase Abutment to obtain a strong bond. Always bond on the master model to ensure precise seating of the coping or crown on the Straumann V ­ ariobase Abutment. Due to the symmetrical nature of the four cams, confirm the position of the crown according to the individual patient anatomy prior to bonding. * Patent pending. 10 Step 2 – Bonding Apply self-adhesive dental cement 3 on the Straumann® Variobase™ Abutment. Follow the cement manufacturer’s instructions. Bond the coping to the Straumann Variobase Abutment. Note • Immediately remove excess cement from the abutment. Polish the lower margin of the coping after the cement has dried • Always use a polishing aid to protect the abutment’s prosthetic ­ connection Warning • Do not fire the abutment after bonding 3 Tested with Panavia™ F2.0 resin cement by Kuraray and a zerion® (zirconium dioxide) coping by Straumann. 11 3.4 Insertion (dentist’s office) The final restoration is fixed on the master cast before it is delivered to the doctor’s office. Step 1 – Preparation • Remove the healing cap or temporary restoration • Remove the superstructure from the master cast and unscrew the abutment from the analog • Clean and dry the interior of the implant and the abutment thoroughly Note Always ensure that surfaces of threads and screw heads are clean and that a new screw is used for the final restoration. Step 2 – Final insertion Option A: Screw-retained final restoration • Position the sterilized Straumann® Variobase™ Abutment with the coping in the implant. Tighten the screw to 35 Ncm using the SCS Screwdriver together with the ratchet and the torque control device • Close the SCS screw channel with cotton and sealing compound (i.e. gutta-percha). This allows for later removal of the Straumann Variobase Abutment in case a crown replacement should be required Option B: Cement-retained final restoration • Position the sterilized Straumann Variobase Abutment in the implant. Tighten the screw to 35 Ncm using the SCS Screwdriver together with the ratchet and the torque control device • Close the SCS screw channel with cotton and sealing compound (i.e. gutta-percha). This allows for later removal of the Straumann Variobase Abutment in case a crown replacement should be required • Cement the superstructure to the abutment • Remove excess cement 12 4.Auxiliaries and instruments. 4.1SCS Screwdrivers Art. No. Article Dimensions Material 046.400 SCS Screwdriver for ratchet, extra short Length 15 mm Cronidur® 30 046.401 SCS Screwdriver for ratchet, short Length 21 mm Cronidur 30 046.402 SCS Screwdriver for ratchet, long Length 27 mm Cronidur 30 4.2Ratchet Art. No. 046.119 4.3 Article Ratchet includes service instrument Dimensions Length 84 mm Material Stainless steel Polishing aids and analog holder Art. No. Article Dimensions Material 046.245 Polishing protector for RN synOcta® Copings, transocclusal screw-retained Length 15 mm Stainless steel 025.2920 025.2920-04 NC Polishing aid Length 16 mm Stainless steel 025.4920 025.4920-04 RC Polishing aid Length 16 mm Stainless steel 046.239 Analog holder Length 105 mm Al/Steel 13 5. Important Guidelines. IMPORTANT GUIDELINES Please note Practitioners must have appropriate knowledge and instruction in the Please note handlingPractitioners of the Straumann CADCAM products orand other Straumann must have appropriate knowledge instruction in the productshandling (“Straumann Products”)CADCAM for usingproducts the Straumann Products of the Straumann or other Straumann safely and properly in accordance with the for use. Products products (“Straumann Products”) for instructions using the Straumann Explanation of the symbols on labels and instruction leaflets Explanation of the symbols on labels and instruction leaflets Batch code Batch code safely and properly in accordance with the instructions for use. Catalogue number Catalogue number The Straumann Product must be used in accordance with the instrucThe Straumann Product must be used in accordance with the tions for use provided by the manufacturer. It is the practitioner’s instructions for use provided by the manufacturer. It is the practitioner’s responsibility to use the device in accordance with these instructions responsibility to use the device in accordance with these instructions for use and to and determine, if theif device fits fits to the for use to determine, the device to theindividual individual patient patient situation.situation. Caution: U.S.U.S. federal lawlaw restricts Caution: federal restricts this thisdevice devicetotosale salebybyororononthethe order order of a dental of aprofessional. dental professional. Do Do notnot re-use re-use The Straumann Products are part of overall an overall conceptand andmust must be The Straumann Products are part of an concept be used only in conjunction with the corresponding original components used only in conjunction with the corresponding original components and instruments distributed by Institut Straumann AG, its ultimate and instruments distributed by Institut Straumann AG, its ultimate parent company and all affiliates or subsidiaries of such parent parent company and all affiliates or subsidiaries of such parent company company (“Straumann”), except if stated otherwise in this document (“Straumann”), if stated otherwise in this document in the or in theexcept instructions for use for the respective StraumannorProduct. instructions forofuse for the made respective Straumann If use of prodIf use products by third parties isProduct. not recommended by Straumann this document or in the respective instructions for ucts made by thirdinparties is not recommended by Straumann in use, this anyorsuch use respective will void any warranty or for other obligation, or document in the instructions use, any suchexpress use will void any implied, warrantyoforStraumann. other obligation, express or implied, of Straumann. Availability Availability Some of the Straumann Products listed in this document may not be Some of available the Straumann Products listed in this document may not be in all countries. available in all countries. Caution Caution In addition to the caution notes in this document, our products must be to secured againstnotes aspiration used intraorally. In addition the caution in thiswhen document, our products must be secured against aspiration when used intraorally. Validity Upon publication of this document, all previous versions are Validity superseded. Upon publication of this document, all previous versions are superseded. Documentation For detailed instructions on the Straumann Products contact your Documentation Straumann representative. For detailed instructions on the Straumann Products contact your Straumann representative. 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Straumann® Straumann Holding AG and/or itsStraumann® affiliates. and/or other trademarks and logos from mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates. 14 Non-sterile Non-sterile Refer to package insert Refer to package insert 0123 Straumann Products with the CE Straumann Products with the CE mark fulfill mark fulfill the requirements of the the requirements of the Medical Devices Medical Devices Directive Directive 93/42 EEC 93/42 EEC Consult instructions Consult instructions for for use use Manufacturer Manufacturer © Straumann USA, LLC 2014. All rights reserved. Straumann® and/or other trademarks and logos from Straumann® that are mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates. 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