CEREC Zirconia meso. Zirconium oxide ceramic blocks for Sirona CAD/CAM systems

Transcription

1 New as of: CEREC Zirconia meso Zirconium oxide ceramic blocks for Sirona CAD/CAM systems Processing instructions: Manufacture of individually designed directly screw-retained crowns on Sirona TiBase English

2 Table of contents Table of contents 1 Introduction Dear Customer, Contact information Copyright General data Certification Structure of the document Identification of the danger levels Formats and symbols used Other relevant documents Scope of supply Material Chemical composition Technical data Intended use, indications and contraindications, and important processing restrictions Intended use Indications Contraindications Important processing restrictions Creating the restoration Scanning, designing and milling/grinding Design information Rework of the grounded/milled restoration Drying before sintering Sintering Additional notes: procedure after sintering Rework Veneer Polishing Painting and coating Recommended tools and materials D

3 Table of contents 10 Glue the directly screw-retained crown onto the titanium base Seal the screw channel Information for the dentist Sterilization Application in the mouth D

4 1 Introduction 1.1 Dear Customer, 1 Introduction 1.1 Dear Customer, Thank you for purchasing the product CEREC Zirconia meso. CEREC Zirconia meso blocks are intended for use in manufacturing individually designed, directly screw-retained crowns and partially reduced, directly screw-retained crowns, which are glued to a fitting titanium base after milling/grinding and sintering. Improper use and handling can create hazards and cause damage. Please therefore read and follow these operating instructions carefully. Always keep them within easy reach. Also pay attention to the safety instructions in this document to prevent personal injury and material damage. Please also observe the instructions provided by the manufacturer of the titanium base or the implant. Your CEREC Consumables Team 1.2 Contact information Manufacturer's address Sirona Dental Systems GmbH Fabrikstrasse Bensheim Germany Tel.: +49 (0) 6251/16-0 Fax: +49 (0) 6251/ contact@dentsplysirona.com Copyright Sirona Dental Systems GmbH. All rights reserved. 4 D

5 2 General data 2.1 Certification 2 General data Please read this document completely and follow the instructions exactly. You should always keep it within reach. Original language of the present document: German. 2.1 Certification 0123 CE mark The CEREC Zirconia meso product bears the CE mark in accordance with the provisions of Council Directive 93/42/EEC of June 14, 1993 concerning medical devices. For the USA only CAUTION: Federal law (USA) restricts sale of this device to or on the order of a physician, dentist, or licensed practitioner. 2.2 Structure of the document Identification of the danger levels To prevent personal injury and material damage, please observe the warning and safety information provided in these operating instructions. Such information is highlighted as follows: DANGER An imminent danger that could result in serious bodily injury or death. WARNING A possibly dangerous situation that could result in serious bodily injury or death. CAUTION A possibly dangerous situation that could result in slight bodily injury. NOTICE A possibly harmful situation which could lead to damage of the product or an object in its environment. IMPORTANT Application instructions and other important information. Tip: Information for simplifying work Formats and symbols used The formats and symbols used in this document have the following meaning: D

6 2 General data 2.3 Other relevant documents Prerequisite 1. First action step 2. Second action step or Alternative action Result Individual action step See Formats and symbols used [ 5] Prompts you to do something. List Designates a list. Command / menu item 2.3 Other relevant documents Identifies a reference to another text passage and specifies its page number. Indicates commands, menu items or quotations. Operating instructions for titanium bases and implants, Operating instructions for the consumables used during application, User manual for the software used (e.g. CEREC SW, CEREC Premium SW, inlab SW), Operating instructions for the sintering furnace used (e.g. CEREC SpeedFire, infirehtc and infirehtc speed). 6 D

7 3 Scope of supply 3 Scope of supply CEREC Zirconia meso blocks are each available in four different classic colors (A1, A2, A3, and A3.5) and in two different sizes for connecting to the titanium base (S and L): CEREC Zirconia meso S Product REF Product name CEREC Zirconia meso S A CEREC Zirconia meso S A CEREC Zirconia meso S A CEREC Zirconia meso S A3.5 CEREC Zirconia meso L Product REF Product name CEREC Zirconia meso L A CEREC Zirconia meso L A CEREC Zirconia meso L A CEREC Zirconia meso L A3.5 The blocks feature identical dimensions of 24 mm x 23 mm x 21.5 mm (L x W x H). D

8 4 Material 4 Material CEREC Zirconia meso ceramics constitute blocks comprised of translucent zirconium oxide. The blocks are initially delivered partially sintered; they are then enlarged with the Sirona CAD/CAM systems for processing as individual restorations before being densely sintered. In the final step, the restorations attain their final size and geometry through shrinkage. The aesthetic features of CEREC Zirconia meso enable application as implant-supported fully anatomical crowns. The advantages of CEREC Zirconia meso include: High strength, Resistance to corrosion, Good biological compatibility of the product, Translucency, Coloration of the blocks to match classic tooth colors A1 - A D

9 5 Chemical composition 5 Chemical composition The chemical composition of the zirconium oxide ceramics of CEREC Zirconia meso is described in the following table: Component CEREC Zirconia meso ZrO 2 +HfO 2 +Y 2 O % Y 2 O 3 > 4.5% - 6.0% HfO 2 5 % Al 2 O % Other oxides 1.1% D

10 6 Technical data 6 Technical data The following specifications apply to material that is densely sintered in a CEREC SpeedFire, infire HTC, or infire HTC speed sintering furnace. Density: 6.08 ± 0.2 g cm -3 Fracture toughness K IC 7.1 MPa m 1/2 Thermal expansion coefficient ( C): K -1 Bending strength: > 900 MPa Grain size 0.4 µm Chemical solubility < 25 µg/cm 2 Colors: The blocks are available in four different classic colors: A1 A2 A3 A D

11 7 Intended use, indications and contraindications, and important processing restrictions 7.1 Intended use 7 Intended use, indications and contraindications, and important processing restrictions 7.1 Intended use Manufacture of individually designed dental restorations from CEREC Zirconia meso blocks using Sirona CAD/CAM systems. CEREC Zirconia meso blocks are intended for use in manufacturing individually designed directly screw-retained crowns, which are glued to a fitting titanium base after milling/grinding and sintering. 7.2 Indications Indications in dentistry areas: Directly screw-retained crown: A fully anatomical crown for the front and lateral tooth area produced via the CAD/CAM process that already has a drill hole in the block. This crown is glued to a fitting titanium base after milling/grinding and sintering and then fixed into the patient's mouth with a screw on an implant. Partially reduced directly screw-retained crown: Like a directly screw-retained crown, but with reduced wall thickness. The partially reduced crown is veneered with veneering ceramics. The screw channel for fixing onto the implant is not sealed with veneering ceramics. In both versions the screw channel is only sealed in the patient's mouth using a composite. Sintering in infire HTC speed and infire HTC Sintering must take place with the pre-programmed Speed and Classic programs in incoris TZI / ZI in infire HTC speed and infire HTC. Sintering in CEREC SpeedFire Sintering must take place with the programs for CEREC Zirconia meso in the CEREC SpeedFire. 7.3 Contraindications Contraindications in areas of dentistry: Insufficient oral hygiene For restorations with angulation correction of more than 20 to the implant axis For individual tooth restorations with free end saddle Insufficient space available For restorations with a length to implant length ratio of more than 1:1.25 D

12 7 Intended use, indications and contraindications, and important processing restrictions 7.4 Important processing restrictions 7.4 Important processing restrictions Working successfully with CEREC Zirconia meso cannot be guaranteed by in the event of a failure to comply with the following instructions: With a directly screw-retained crown the outlet for the screw channel must not be in the area around the contact points or be on functional masticatory surfaces. A frame and separate crown is preferred if this is not possible. Failure to observe the manufacturer's instructions for processing titanium bases and implants. No extension links, i.e. exclusively individual tooth supply. 12 D

13 8 Creating the restoration 8.1 Scanning, designing and milling/grinding 8 Creating the restoration 8.1 Scanning, designing and milling/grinding Further details on the manufacturing processes for the restorations can be found in the user manuals for the following software products: CEREC SW CEREC Premium SW inlab SW 1. When working on the model: Plug a titanium base onto the lab implant of the master model. Plug a scanbody onto this until it comes to rest on the shoulder of the implant without any gaps. The scanbody is scannable without powder or scan spray. For intraoral working: Plug a ScanPost directly onto the implant. Plug a scanbody onto this until it comes to rest on the shoulder of the implant without any gaps. The scanbody is scannable without powder or scan spray. 2. Scan the situation with a scanner, e.g. ineos Blue, ineos X5 or an acquisition unit. 3. Design the individual shape of the directly screw-retained crown with one of the software products CEREC SW, CEREC Premium SW or inlab SW and mill/grind the shape from a CEREC Zirconia meso block (see user manual). The following information must be observed when designing, reworking and sintering zirconium oxide. IMPORTANT The manual trim function should be used for optimum results with CEREC Zirconia meso during the restoration design process using one of the aforementioned software products. The design proposals must be reviewed with particular care if the "Auto Trim" function is used. In some cases the thickness of the approximal contacts cannot be displayed correctly. D

14 8 Creating the restoration 8.2 Design information 8.2 Design information A B Screw channel Titanium base Maintain a minimum wall thickness of 0.5 mm circularly around the screw channel. The outlet point for the screw channel should not be in the area around the contact points to the antagonist wherever possible. If the crown is to be reduced and then veneered immediately, make sure that this does not narrow the screw channel. The connection point to the adhesive base and the screw channel must not be changed. Make sure that no sharp edges or corners are produced. The incisal/occlusal wall thickness of the ceramic above the titanium base should be at least 1 mm. The circular wall thickness above the titanium base should be at least 1 mm. 14 D

15 8 Creating the restoration 8.3 Rework of the grounded/milled restoration 8.3 Rework of the grounded/milled restoration After the grinding/milling process and prior to sintering, the restoration must be separated using a carbide milling machine ( recommends: HM489FC 023 from Meissinger). To prevent milling residues from remaining in the fissures, the restoration can be briefly steamed off or cleaned with water and a soft toothbrush. In the case of dry-milled restorations we recommend that these are freed from dust using a ceramic brush or compressed air. Make sure you do not inhale abrasive dusts. Use a vacuum system and wear a mask. Block remains and the block holder do not need to be disposed of separately. They can be disposed of as normal household waste. This also applies to trepanated restorations. 8.4 Drying before sintering No drying is required for dry-milled restorations (with no water cooling). The CEREC software makes a drying program available for the CEREC SpeedFire furnace for drying restorations. NOTICE Prior to sintering in the infire HTC or infire HTC speed, restorations processed with water cooling (wet milling/wet grinding) must be dried for 10 minutes at 150 C (302 F) in the drying cabinet. Residual moisture in the material can cause the restorations to burst. NOTICE In the case of high humidity In an environment with a high level of humidity, the restorations can absorb moisture after drying. For this reason, sintering must take place within a maximum of one hour after drying. D

16 8 Creating the restoration 8.5 Sintering 8.5 Sintering Restorations made from CEREC Zirconia meso have to be sintered in dry conditions. The Sirona infire HTC, infire HTC speed and CEREC SpeedFire sintering furnaces offer programs with a pre-drying function. In addition the restorations processed with water cooling (wet milling/ wet grinding) must be pre-dried beforehand for 10 minutes at 150 C (302 F) in the drying cabinet for sintering in the infire HTC and infire HTC speed furnaces. The sintering process should preferably be performed in a Sirona sintering furnace. When sintering in the infire HTC/HTC speed, use the pre-programmed incoris TZI / ZI program. When sintering in the CEREC SpeedFire, the CEREC software automatically selects the program. Observe the information in the operating instructions for the furnace. The classic program for sintering with CEREC Zirconia meso is the same as for incoris TZI / ZI. The sintering result from furnaces other than those specified here cannot be guaranteed by. As an alternative, the sintering process can be carried out in the compatible VITA Zyrcomat or Ivoclar Vivadent Sintramat high temperature furnaces. Use the following zirconium oxide program for this. Sintering program for other furnaces Heating rate C/min Holding temperature C Holding time min In any case, the details in the manuals for the respective furnaces are to be adhered to. Sintering in CEREC SpeedFire When sintering in the CEREC SpeedFire furnace, place the restorations with the occlusal surface directly on the top door insulation. NOTICE Maximum Observe restoration size Observe the maximum Furnace chamber size when loading the furnace. - Diameter: 38 mm - Height: 20 mm The restoration must be placed on the labial surface when sintering if the restoration exceeds 20 mm (block height 22 mm). 16 D

17 8 Creating the restoration 8.5 Sintering Sintering in infire HTC or infire HTC speed When using an infire HTC or infire HTC speed, place the restorations in the sintering tray with the occlusal surface on the sintering beads. If several restorations are sintered at the same time, these must not touch the edge of the sintering tray or each other. Notes on sintering in an infire HTC speed from serial numbers 5000 to 5699 NOTICE Reprogramming heat curves As a result of a modified component in infire HTC speed from serial numbers 5000 to 5699, depending on the local power grid your furnace may show signs of an increased heating rate. Please program the following heat curves for CEREC Zirconia meso and use this or the "classic" program for sintering. For speed sintering "speed": On program stations 20 to 26: Heating speed C/min Holding temperature C S S S S For speed sintering with pre-drying "speed + dry": On program station 27 or 28: Heating speed C/min Holding temperature C S S S S For speed sintering "speed + air": On program station 29 or 30: Heating speed C/min Holding temperature C S S S S Holding time min Holding time min Holding time min D

18 8 Creating the restoration 8.6 Additional notes: procedure after sintering 8.6 Additional notes: procedure after sintering In the case of yellow staining of CEREC Zirconia meso restorations after the sintering process, the high-temperature furnace should be cleansed by performing an empty run. The details in the manuals for the respective furnaces are to be adhered to in this case. This is not necessary for CEREC SpeedFire due to the different heating concept. Sintering beads that adhere are to be removed carefully. After the sintering process, the restorations from CEREC Zirconia meso blocks must be cooled down to room temperature before further processing. 8.7 Rework The surface condition of ceramic materials is decisive for their bending strength. Reworking sintered restorations with milling tools, especially in the connector region, must be avoided at all costs. Corrections to the grounded restoration should be completed if possible before sintering. One of the following tools should be used if rework is required in sintered state: Wet grinding turbines (approx. 2.5 bar - 3 bar), Rubber polisher (low speed), With primary telescopes, a milling device with water cooling and low grinding pressure, Soft diamond rubber polisher ( recommends: EVE DIASYNT PLUS / DIACERA). Follow the manufacturer's instructions for the tools. The sintered restorations should also be polished prior to applying the enamel coating in order to prevent abrasion to the antagonist following potential loss of shine. CEREC Zirconia meso can be polished with all standard polishing agents for zirconia ceramics ( recommends: EVE DIASYNT PLUS / DIACERA). Subsequent heat treatment (depressurization fire) is not necessary. NOTICE Observe usage information Etching with hydrofluoric acid does not produce a retentive surface. Silanization is not required Please observe the information on use of the fastening materials of the corresponding manufacturers. 18 D

19 8 Creating the restoration 8.8 Veneer 8.8 Veneer The areas of the reduced crowns to be veneered that are made of CEREC Zirconia meso may not be sandblasted or reworked. Sandblasting could lead to an undesirable phase transformation of the zirconium dioxide. For the veneer, this would cause complex diffusions of stress along the interface which might lead to cracks or late cracks in the veneer after the restoration is inserted. Make sure that the screw channel is not narrowed when the veneering ceramics is applied. The connection point to the adhesive base and the screw channel must not be changed. Reduced crowns made of CEREC Zirconia meso can be veneered with veneering ceramics for zirconium oxide ceramics ( recommends: Cercon Ceram Kiss from ). In this case the manufacturer's processing instructions must be observed without fail. 8.9 Polishing The sintered restorations should also be polished prior to applying the enamel coating in order to prevent abrasion to the antagonist following potential loss of shine. Restorations made from CEREC Zirconia meso can be polished with rubber polisher ( recommends: EVE DIASYNT PLUS / DIACERA) for processing zirconium oxide. Subsequent heat treatment (depressurization fire) is not necessary Painting and coating Restorations made from CEREC Zirconia meso can be finalized using paints for zirconium oxide ceramics. Celtra Universal Stain from is suitable for this purpose. In this case the processing instructions for the relevant product must be observed without fail. Restorations made from CEREC Zirconia meso blocks can be finalized using glazes for zirconium oxide ceramics. CEREC SpeedGlaze from Sirona and Celtra Universal Stain & Glaze from are suitable for this purpose. NOTICE No glaze on/in the adhesive area/screw channel No glaze must under any circumstances get onto the adhesive area for the restoration to the titanium base or into the screw channel as this impairs the fit. D

20 8 Creating the restoration 8.10 Painting and coating The following step-by-step instructions illustrate the glazing process using the CEREC SpeedFire furnace as an example. 1. Always use a slim restoration holder wherever possible for glazing restorations which does not touch the inner surfaces when glazing. Use the "Glasur Support Single Unit" restoration holder from Sirona. 2. Use the CEREC SpeedPaste from Sirona for fastening onto the restoration holder and for closing the screw channel. 3. Press the thinnest tapered pin into the screw channel filled with CEREC SpeedPaste. 4. Spread/model the CEREC SpeedPaste in such a way that the screw channel is sealed and the adhesive surface to the TiBase is covered and no glaze/spray can get onto these surfaces. 20 D

21 9 Recommended tools and materials 9 Recommended tools and materials Handpiece: KaVo K11 Grinding tools for reworking with the wet grinding turbine/with handpiece: Carbide milling machine HM489FX 023 (Meissinger Germany), EVE DIASYNT PLUS / DIACERA, diamond polishing system for processing zirconium oxide. Other: CEREC SpeedGlaze (Sirona), CEREC SpeedPaste (Sirona), Glasur Support Single Unit (Sirona), Celtra Universal Stain & Glaze (), Cercon Ceram Kiss (), Panavia F2.0 (Kuraray), ceram.x duo (). D

22 10 Glue the directly screw-retained crown onto the titanium base 10 Glue the directly screw-retained crown onto the titanium base Prior to gluing, check to make sure that the crown can be easily placed on the titanium base. No gap should be visible between the restoration and the attachment surface of the titanium base. CAUTION Observe the manufacturer s instructions for handling the titanium base. The contact surfaces of the titanium base to the implant should not be sand-blasted or otherwise processed. The diameter of the titanium base should not be reduced (e.g. by grinding). Shortening the titanium base is not recommended. The surfaces of the titanium base intended for gluing to the zirconium oxide ceramics have to be sand-blasted and cleaned. Surfaces of the zirconium oxide ceramics and the titanium base to be glued must be free of dust and grease. 1. Sand-blast the gluing surfaces of the zirconium oxide ceramics and the titanium base with 50 µm aluminum oxide and up to 2.0 bar. (The screw channel of the zirconium oxide ceramics is also an adhesive surface and must be treated accordingly with the sandblasting technique.) 2. Clean the adhesive surfaces with alcohol or steam. For easier handling during the gluing process, it is recommended that the titanium base be screwed into a lab implant or a polishing tool. 3. Cover the hex head of the abutment screw with wax. NOTICE Use "PANAVIA F 2.0" ( extraoral as the adhesive for connecting the titanium base and the zirconium oxide ceramics. 4. Apply Alloy Primer (from Kuraray Noritake Dental Inc.) onto the TiBase adhesive surface in accordance with the manufacturer's instructions. 5. Mix the glue according to the manufacturer's instructions and apply it to the titanium base. 6. Press on the customized zirconium oxide ceramics as far as it will go. Make sure it latches into the rotation and position stops. 7. Remove excess glue immediately. 8. Apply the Airblocker ("Oxygard") to the junction where the ceramic and titanium surfaces meet and to the screw funnel for final hardening. 9. Remove residue with a rubber polisher after hardening. 22 D

23 11 Seal the screw channel 11 Seal the screw channel 1. Seal the screw channel with a filling composite using a dental adhesive compatible with zirconium oxide as used to produce a standard occlusal dental filling. Follow the relevant processing instructions from the manufacturer (hardening times for adhesive and filling composite and layer thicknesses with the filling composite). The composite ceram.x duo and dental adhesive Prime&Bond active from are suitable for this purpose. 2. Once the composite has hardened polish the surface following the composite manufacturer's instructions. IMPORTANT Use the following composite colors for the different color variants: - A1 ceram.x duo D2 - A2 ceram.x duo D2 - A3 ceram.x duo D3 - A3.5 ceram.x duo D4 D

24 12 Information for the dentist 12.1 Sterilization 12 Information for the dentist The titanium bases are delivered in non-sterile condition. Observe the implant manufacturer's operating instructions Sterilization The individual abutments and abutment screws must be cleaned and sterilized prior to insertion. Furthermore, the locally applicable legal regulations and the hygiene standards applicable for a dental practice must be observed. Use only the validated sterilization procedures specified below to sterilize individual abutments. Observe the sterilization parameters. Use a steam sterilizer to sterilize the unwrapped individual abutment and screw with a pre-vacuum cycle (135 C / 275 F for 3 minutes). The responsibility for the sterility of the individual abutment lies with the user. It must be ensured that only suitable devices, materials and product-specifically validated methods are used to perform sterilization. It must be ensured that the methods used have been validated. The equipment and devices must be properly maintained and serviced at regular intervals. The fabricator (dental technician) of the TiBase and of the directly screw-retained crown must inform the dentist of the need to sterilize the abutment before inserting it in the patient's mouth! 12.2 Application in the mouth WARNING Risk of aspiring small parts Position the patient in such a way that the risk of aspiring small parts is kept to a minimum. Secure all intraorally used components against aspiration and being swallowed. Use the unused abutment screw and the tools provided by the implant manufacturer to screw the TiBase onto the implant, observing the tightening torques specified. 24 D

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26 We reserve the right to make any alterations which may be required due to technical improvements. Sirona Dental Systems GmbH Sprache: englisch Printed in Germany D Ä.-Nr.: Sirona Dental Systems GmbH Fabrikstr Bensheim Germany Order No