CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. May 7, 2024 Dentsply Sirona Rebecca Sporer Principal Regulatory Affairs Specialist 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401 Re: K234018 Trade/Device Name: CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: December 19, 2023 Received: April 5, 2024 Dear Rebecca Sporer: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory- assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K234018 ### Device Name CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System ### Indications for Use (Describe) CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - CEREC Cercon 4D™ Abutment Block - TiBase - CAD/CAM system The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. Implant Systems: • Dentsply Sirona: PrimeTaper EV, OmniTaper EV, AstraTech OsseoSpeed TX, Frialit / XiVE, AstraTech Implant EV, Ankylos - · BioHorizons: Internal connection · Nobel Biocare: Replace Select, Nobel Active, NobelReplace Conical Connection, Brânemark, NobelSpeedy Groovy - · Straumann: Tissue Level, Bone Level - · Thommen Medical: Element, Contact - · Osstem/Hiossen: Osstem TS, USA: Hiossen ET - · Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent - · MIS: C1 Conical Connection, V3 Conical Connection, SEVEN internal hex, M4 internal hex - · Altatec Camlog CAD/CAM Systems: ·Sirona Dental CAD/CAM System Manufacturer: Dentsply Sirona Implant Implant: Primetaper EV Platform: S; TiBase AT EV 3.6 GH 1 S; Reference: 6586312; Size: S Platform: M; TiBase AT EV 4.2 GH 1 L; Reference: 6586320; Size: L Platform: L; TiBase AT EV 4.8 GH 1 L; Reference: 6586338; Size: L Manufacturer: Dentsply Sirona Implant Implant: AstraTech OsseoSpeed TX Platform 3.5 / 4.0; TiBase AT TX 3.5/4.0 GH 1 L; Reference: 6598093; Size: L Platform 4.5 / 5.0; TiBase AT TX 4.5/5.0 GH 1 L; Reference: 6598101; Size: L Platform 3.5 / 4.0; TiBase AT OS 3.5/4.0 GH 1 L; Reference: 6282532; Size: L Platform 4.5 / 5.0; TiBase AT OS 4.5/5.0 GH 1 L; Reference: 6282540; Size: L Manufacturer: Dentsply Sirona Implant Implant: Frialit / XiVE Platform: 3.4; TiBase FX 3.4 GH 1 S; Reference: 6282433; Size: S {4}------------------------------------------------ Platform: 3.8; TiBase FX 3.8 GH 1 S; Reference: 6282441; Size: S Platform: 4.5; TiBase FX 4.5 GH 1 L; Reference: 6282458; Size: L Platform: 5.5; TiBase FX 5.5 GH 1 L; Reference: 6282466; Size: L Manufacturer: Dentsply Sirona Implant Implant: AstraTech Implant EV Platform: XL; TiBase AT EV 5.4 GH 1 L; Reference: 66586346; Size: L Manufacturer: Dentsply Sirona Implant Implant: Ankylos Platform: C/X; TiBase ANK C/ GH 1 S; Reference: 6586528; Size: S Platform: C/X; TiBase ANK C/ GH 2 S; Reference: 6586536; Size: S Platform: C/X; TiBase ANK /X GH 1 S; Reference: 6586544; Size: S Platform: C/X: TiBase ANK /X GH 2 S; Reference: 6586551; Size: S Manufacturer: BioHorizons Implant: Internal Connection Platform: 3.0; TiBase BH 3.0 GH 1 S; Reference: 6532779; Size: S Platform: 3.5; TiBase BH 3.5 GH 1 L; Reference: 6532894; Size: L Platform: 4.5; TiBase BH 4.5 GH 1 L; Reference: 6532951; Size: L Platform: 5.7; TiBase BH 5.7 GH 1 L; Reference: 6536242; Size: L Manufacturer: Nobel Biocare Implant: Replace, Replace Select Platform: NP; TiBase NB RS 3.5 GH 1 L; Reference: 6282474; Size: L Platform: RP; TiBase NB RS 4.3 GH 1 L; Reference: 6282482; Size: L Platform: WP; TiBase NB RS 5.0 GH 1 L; Reference: 6282490; Size: L Platform: 6.0; TiBase NB RS 6.0 GH 1 L; Reference: 6282508; Size: L Implant: Nobel Active Platform: NP; TiBase NB A 4.5 GH 1 L; Reference: 6308188; Size: L Implant: NobelReplace Conical Connection Platform: RP; TiBase NB A 5.0 GH 1 L; Reference: 6308253; Size: L Implant: Brånemark Platform: NP, TiBase NB B 3.4 GH 1 L; Reference: 6282516; Size: L Implant: NobelSpeedy Groovy Platform: RP; TiBase NB B 4.1 GH 1 L; Reference: 6282524; Size: L Manufacturer: Straumann Implant: Tissue Level Platform: RN (4.8 mm): TiBase SSO 4.8 GH 1 L: Reference: 6284249; Size: L Platform: WN (6.5 mm); TiBase SSO 6.5 GH 1 L; Reference: 6284256; Size: L Implant: Bone Level Platform: NC (3.3 mm); TiBase S BL 3.3 GH 1 L; Reference: 6308154; Size: L Platform: RC (4.1 mm / 4.8 mm); TiBase S BL C 4.1 GH 1 L; Reference: 6308337; Size: L Manufacturer: Thommen Medical Implant: Element, Contact Platform: 3.5; TiBase TM 3.5 GH 1 S; Reference: 6531854; Size: S Platform: 4; TiBase TM 4 GH 1 S; Reference: 6532829; Size: S {5}------------------------------------------------ Platform: 4.5; TiBase TM 4.5 GH 1 S; Reference: 6532837; Size: S Platform: 5; TiBase TM 5 GH 1 S; Reference: 6544360; Size: S Platform: 6; TiBase TM 6 GH 1 S; Reference: 6544378; Size: S Manufacturer: Osstem / Hiossen Implant: Osstem TS (US Hiossen ET) Platform: Mini; TiBase O TS 3.5 GH 1 L; Reference: 6527035; Size: L Platform: Regular; TiBase O TS 4.0 GH 1 L; Reference: 6527043; Size: L Manufacturer: Zimmer / Biomet Implant: External hex Platform: 3.4; TiBase B O 3.4 GH 1 L; Reference: 6282557; Size: L Platform: 4.1; TiBase B O 4.1 GH 1 L; Reference: 6282565; Size: L Platform: 5.0; TiBase B O 5.0 GH 1 L; Reference: 6282573; Size: L Implant: Certain Platform: 3.4; TiBase B C 3.4 GH 1 S; Reference: 6308048; Size: S Platform: 4.1; TiBase B C 4.1 GH 1 L; Reference: 6308097; Size: L Platform: 5.0; TiBase B C 5.0 GH 1 L; Reference: 6308121; Size: L Implant: Tapered Screw-Vent Platform: 3.5; TiBase Z TSV 3.5 GH 1 L; Reference: 6282581; Size: L Platform: 4.5; TiBase Z TSV 4.5 GH 1 L; Reference: 6282599; Size: L Platform: 5.7; TiBase Z TSV 5.7 GH 1 L; Reference: 6282607; Size: L Manufacturer: M.I.S. Implants Implant: C1 Conical Connection Platform: NP; TiBase CN-TB001 C1 NP GH 0.5; Reference: CN-TB001; Size: L Platform: NP: TiBase CN-B015 C1 NP GH 1.5; Reference: CN-TB015; Size: L Implant: V3 Conical Connection Platform: NP; TiBase VN-TB001 V3 NP GH 0.5; Reference: VN-TB001; Size: L Platform: NP; TiBase VN-TB015 V3 NP GH 1.5; Reference: VN-TB015; Size: L Implant: V3 Conical Connection / C1 Conical Connection Platform: SP; TiBase CS-TB001 SP GH 0.5; Reference: CS-TB001; Size: L Platform: SP; TiBase CS-TB015 SP GH 1.5; Reference: CS-TB015; Size: L Platform: SP; TiBase CS-TB030 SP GH 3; Reference: CS-TB030; Size: L Implant: C1 Conical Connection Platform: WP; TiBase CW-TB001 C1 WP GH 0.5; Reference: CW-TB001; Size: L Platform: WP; TiBase CW-TB015 C1 WP GH 1.5; Reference: CW-TB015; Size: L Platform: WP; TiBase CW-TB030 C1 WP GH 3; Reference: CW-TB030; Size: L Implant: SEVEN internal hex, M4 internal hex Platform: NP; TiBase MN-TB001 INT HEX NP GH 0.5; Reference: MN-TB001; Size: L Platform: NP; TiBase MN-TBC15 INT HEX NP GH 1.5; Reference: MN-TBC15; Size: L Platform: SP; TiBase MD-TB001 INT HEX SP GH 0.5; Reference: MD-TB001; Size: L Platform: SP; TiBase MD-TBC15 INT HEX SP GH 1.5; Reference: MD-TBC15; Size: L Platform: SP; TiBase MD-TBC30 INT HEX SP GH 3; Reference: MD-TBC30; Size: L Platform: WP; TiBase MW-TB001 INT HEX WP GH 0.5; Reference: MW-TB001; Size: L Platform: WP; TiBase MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L Platform: WP; TiBase MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L {6}------------------------------------------------ Manufacturer: Straumann Implant: Tissue Level Platform: NNC (3.5 mm); TiBase NNC Variobase C 3.5 GH 1; Reference: 220.018; Size: S Platform: RN (4.8 mm): TiBase RN Varionbase C 3.5 GH 1; Reference: 220.019; Size: L Platform: WN (6.5 mm); TiBase WN Variobase C GH 1; Reference: 220.020; Size: L Implant: Bone Level Platform: NC (3.3 mm); TiBase NC Variobase C 3.3 GH 1; Reference: 220.043; Size: S Platform: RC (4.1 mm / 4.8 mm); TiBase RC Variobase C 4.1 GH 1; Reference: 220.044; Size: L Manufacturer: Altatec GmbH-Camlog Implant: Camlog Platform: 3.3; CAMLOG Titanium Base CADM/CAM, for Ø 3.3 mm GH 0.4; Reference K2244.3348; Size S Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for Ø 3.8 mm GH 0.3; Reference: K2244.3848; Size: S Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for Ø 4.3 mm GH 0.3; Reference: K2244.4348; Size: S Platform: 5.0; CAMLOG Titanium Base CAD/CAM, for Ø 5.0 mm GH 0.3; Reference K2244.5048; Size: L Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for Ø 6.0 mm GH 0.3; Reference K2244.6048; Size: L Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {7}------------------------------------------------ Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 Image /page/7/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a blue abstract shape on the left and the words "Dentsply Sirona" in blue on the right. The abstract shape is made up of two curved lines that form an S shape. The text is in a sans-serif font. # 510(k) SUMMARY ### for ### CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (K234018) - 1. Submitter Information: Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401 | Contact Person: | Rebecca Sporer | |-------------------|---------------------------------| | Telephone Number: | 717-849-4793 | | Email: | Corporate-RA@dentsplysirona.com | | Date Prepared: | 02 May 2024 | - 2. Device Name: - CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Proprietary Name: ● - Abutment System - Classification Name: Endosseous dental implant abutment - 872.3630 ● CFR Number: - . Device Class: Class II - Primary Product Code: NHA . - . Secondary Product Code: PNP #### 3. Predicate/Reference Devices: | Predicate Device Name | 510(k) | Company Name | |----------------------------------------------------------------|---------|-----------------| | CEREC Tessera Abutment Block, CEREC Tessera<br>Abutment System | K221402 | Dentsply Sirona | | Reference Device Name | 510(k) | Company Name | |------------------------------------------------------------------------------|---------|-----------------| | Technological characteristics / Performance / Composition / Biocompatibility | | | | Sirona Dental CAD/CAM System (inCoris ZI meso material) | K111421 | Dentsply Sirona | | Material Composition / Biocompatibility Only | | | | Cercon | K162888 | Dentsply Sirona | | Reverse Engineering Compatibility Testing | | | | Sirona Dental CAD/CAM System with inLab Software | K200191 | Dentsply Sirona | | Sirona Dental CAD/CAM System with CEREC Chairside Software | K193408 | Dentsply Sirona | | Sirona Dental CAD/CAM System | K181520 | Dentsply Sirona | | Sirona Dental CAD/CAM System | K100152 | Dentsply Sirona | {8}------------------------------------------------ | Compatible Dental Implants | 510(k) | Company Name | |-----------------------------------------------------------------------------------------|---------------------------------------------|-----------------| | PrimeTaper EV | K210610 | Dentsply Sirona | | OmniTaper EV | K221094 | Dentsply Sirona | | AstraTech OsseoSpeed TX | K053384 | Dentsply Sirona | | Frialit/ XiVE | K013867 | Dentsply Sirona | | AstraTech Implant EV | K120414 | Dentsply Sirona | | Ankylos | K083805 | Dentsply Sirona | | Internal Connection | K143022,<br>K071638,<br>K093321,<br>K042429 | BioHorizons | | Replace, Replace Select | K020646 | Nobel Biocare | | Nobel Active and NobelReplace Conical Connection | K071370 | Nobel Biocare | | Branemark and NobelSpeedy Groovy | K022562 | Nobel Biocare | | Straumann Tissue Level and Bone Level | K151324 | Straumann | | Element, Contact | K093615,<br>K090154 | Thommen Medical | | Osstem TS (Hiossen ET) | K121585 | Osstem/Hiossen | | External Hex, Certain and Tapered Screw-Vent | K061410,<br>K061629,<br>K014235 | Zimmer/Biomet | | C1 Conical Connection, V3 Conical Connection,<br>SEVEN internal hex and M4 internal hex | K191152 | Dentsply Sirona | | Camlog | K083496 | Altatec GmbH | ## 4. Description of Device: The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials. CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to the TiBase (Titanium base) used with dental implant systems. The following patient-specific ranges for CAD/CAM fabrication of the subject abutments are: - . Maximum angulation of 200 - . Minimal wall thickness of 0.5 mm - Gingival height ranges from 0.3-2.0 mm ● - Minimum abutment post height (i.e. length above the gingival height) of ≥ 4 mm . {9}------------------------------------------------ - 5. Indications for Use: CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: - CEREC Cercon 4D™ Abutment Block - TiBase - CAD/CAM system The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for twopiece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. Implant Systems: - Dentsply Sirona: PrimeTaper EV, OmniTaper EV, AstraTech OsseoSpeed TX, . Frialit / XiVE , AstraTech Implant EV , Ankylos - BioHorizons: Internal connection . - Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Conical . Connection, Brånemark, NobelSpeedy Groovy - Straumann: Tissue Level, Bone Level ● - Thommen Medical: Element, Contact - Osstem/Hiossen: Osstem TS, USA:Hiossen ET - Zimmer/Biomet: External hex, Certain, Tapered Screw-Vent ● - MIS: C1 Conical Connection, V3 Conical Connection, SEVEN internal hex, M4 ● internal hex - . Altatec - Camlog CAD/CAM Systems: - Sirona Dental CAD/CAM System . {10}------------------------------------------------ # Compatible TiBase and Implant Systems | Implant System | | Titanium Base | | | |----------------------------------------|----------------------|-------------------------------------------------------|------------|------| | Manufacturer / line | Platform | Name | REF | Size | | Dentsply Sirona Implants | S | TiBase AT EV 3.6 GH 1 S | 6586312 | S | | Primetaper EV | M | TiBase AT EV 4.2 GH 1 L | 6586320 | L | | | L | TiBase AT EV 4.8 GH 1 L | 6586338 | L | | | 3.5 / 4.0 | TiBase AT TX 3.5/4.0 GH 1 L | 6598093 | L | | AstraTech<br>OsseoSpeed TX | 4.5 / 5.0 | TiBase AT TX 4.5/5.0 GH 1 L | 6598101 | L | | | 3.5 / 4.0 | TiBase AT OS 3.5/4.0 GH 1 L | 6282532 | L | | | 4.5 / 5.0 | TiBase AT OS 4.5/5.0 GH 1 L | 6282540 | L | | Frialit / Xive | 3.4 | TiBase FX 3.4 GH 1 S | 6282433 | S | | | 3.8 | TiBase FX 3.8 GH 1 S | 6282441 | S | | | 4.5 | TiBase FX 4.5 GH 1 L | 6282458 | L | | | 5.5 | TiBase FX 5.5 GH 1 L | 6282466 | L | | AstraTech Implant<br>EV | XL | TiBase AT EV 5.4 GH 1 L | 6586346 | L | | Ankylos | C/X | TiBase ANK C/ GH 1 S | 6586528 | S | | | | TiBase ANK C/ GH 2 S | 6586536 | S | | | | TiBase ANK /X GH 1 S | 6586544 | S | | | | TiBase ANK /X GH 2 S | 6586551 | S | | BioHorizons | | | | | | Internal connection | 3.0 | TiBase BH 3.0 GH 1 S | 6532779 | S | | | 3.5 | TiBase BH 3.5 GH 1 L | 6532894 | L | | | 4.5 | TiBase BH 4.5 GH 1 L | 6532951 | L | | | 5.7 | TiBase BH 5.7 GH 1 L | 6536242 | L | | Nobel Biocare | | | | | | Replace, Replace<br>Select | NP | TiBase NB RS 3.5 GH 1 L | 6282474 | L | | | RP | TiBase NB RS 4.3 GH 1 L | 6282482 | L | | | WP | TiBase NB RS 5.0 GH 1 L | 6282490 | L | | | 6.0 | TiBase NB RS 6.0 GH 1 L | 6282508 | L | | Nobel Active | NP | TiBase NB A 4.5 GH 1 L | 6308188 | L | | NobelReplace<br>Conical Connection | RP | TiBase NB A 5.0 GH 1 L | 6308253 | L | | Brånemark | NP | TiBase NB B 3.4 GH 1 L | 6282516 | L | | NobelSpeedy<br>Groovy | RP | TiBase NB B 4.1 GH 1 L | 6282524 | L | | Straumann | | | | | | Tissue Level | RN (4.8 mm) | TiBase SSO 4.8 GH 1 L | 6284249 | L | | | WN (6.5 mm) | TiBase SSO 6.5 GH 1 L | 6284256 | L | | Bone Level | NC (3.3 mm) | TiBase S BL 3.3 GH 1 L | 6308154 | L | | | RC (4.1 mm / 4.8 mm) | TiBase S BL 4.1 GH 1 L | 6308337 | L | | Thommen Medical | | | | | | Element, Contact | 3.5 | TiBase TM 3.5 GH 1 S | 6531854 | S | | | 4 | TiBase TM 4 GH 1 S | 6532829 | S | | | 4.5 | TiBase TM 4.5 GH 1 S | 6532837 | S | | | 5 | TiBase TM 5 GH 1 S | 6544360 | S | | | 6 | TiBase TM 6 GH 1 S | 6544378 | S | | | Implant System | Titanium Base | | | | Manufacturer / line | Platform | Name | REF | Size | | Osstem / Hiossen | | | | | | Osstem TS | Mini | TiBase O TS 3.5 GH 1 L | 6527035 | L | | (USA: Hiossen ET) | Regular | TiBase O TS 4.0 GH 1 L | 6527043 | L | | Zimmer /Biomet | | | | | | | 3.4 | TiBase B O 3.4 GH 1 L | 6282557 | L | | External hex | 4.1 | TiBase B O 4.1 GH 1 L | 6282565 | L | | | 5.0 | TiBase B O 5.0 GH 1 L | 6282573 | L | | | 3.4 | TiBase B C 3.4 GH 1 S | 6308048 | S | | Certain | 4.1 | TiBase B C 4.1 GH 1 L | 6308097 | L | | | 5.0 | TiBase B C 5.0 GH 1 L | 6308121 | L | | | 3.5 | TiBase Z TSV 3.5 GH 1 L | 6282581 | L | | Tapered Screw-Vent | 4.5 | TiBase Z TSV 4.5 GH 1 L | 6282599 | L | | | 5.7 | TiBase Z TSV 5.7 GH 1 L | 6282607 | L | | M.I.S | | | | | | C1 Conical | NP | CN-TB001 C1 NP GH 0.5 | CN-TB001 | L | | Connection | | CN-TB015 C1 NP GH 1.5 | CN-TB015 | L | | V3 Conical | | VN-TB001 V3 NP GH 0.5 | VN-TB001 | L | | Connection | NP | VN-TB015 V3 NP GH 1.5 | VN-TB015 | L | | V3 Conical | | CS-TB001 SP GH 0.5 | CS-TB001 | L | | Connection, C1 | SP | CS-TB015 SP GH 1.5 | CS-TB015 | L | | Conical Connection | | CS-TB030 SP GH 3 | CS-TB030 | L | | | | CW-TB001 C1 WP GH 0.5 | CW-TB001 | L | | C1 Conical<br>Connection | WP | CW-TB015 C1 WP GH 1.5 | CW-TB015 | L | | | | CW-TB030 C1 WP GH 3 | CW-TB030 | L | | | | MN-TB001 INT HEX NP GH 0.5 | MN-TB001 | L | | | NP | MN-TBC15 INT HEX NP GH 1.5 | MN-TBC15 | L | | | | MD-TB001 INT HEX SP GH 0.5 | MD-TB001 | L | | SEVEN internal hex,<br>M4 internal hex | SP | MD-TBC15 INT HEX SP GH 1.5 | MD-TBC15 | L | | | | MD-TBC30 INT HEX SP GH 3 | MD-TBC30 | L | | | WP | MW-TB001 INT HEX WP GH 0.5 | MW-TB001 | L | | | | MW-TBC15 INT HEX WP GH 1.5 | MW-TBC15 | L | | | | MW-TBC30 INT HEX WP GH 3 | MW-TBC30 | L | | Straumann | | | | | | | NNC (3.5 mm) | NNC Variobase C 3.5 GH 1 | 220.018 | S | | Tissue Level | RN (4.8 mm) | RN Variobase C GH 1 | 220.019 | L | | | WN (6.5 mm) | WN Variobase C GH 1 | 220.020 | L | | Bone Level | NC (3.3 mm) | NC Variobase C 3.3 GH 1 | 220.043 | S | | | RC (4.1 mm / 4.8 mm) | RC Variobase C 4.1 GH 1 | 220.044 | L | | Camlog | | | | | | | 3.3 | CAMLOG® Titanium base CAD/CAM, for Ø 3.3 mm GH<br>0.4 | K2244.3348 | S | | Camlog | 3.8 | CAMLOG® Titanium base CAD/CAM ,for Ø 3.8 mm GH<br>0.3 | K2244.3848 | S | | | 4.3 | CAMLOG® Titanium base CAD/CAM, for Ø 4.3 mm GH<br>0.3 | K2244.4348 | S | | | 5.0 | CAMLOG® Titanium base CAD/CAM, for Ø 5.0 mm GH<br>0.3 | K2244.5048 | L | | | 6.0 | CAMLOG® Titanium base CAD/CAM, for Ø 6.0 mm GH<br>0.3 | K2244.6048 | L | {11}------------------------------------------------ {12}------------------------------------------------ #### Substantial Equivalence: 6. The indications for use of the proposed device do not constitute a new intended use. The proposed CEREC Cercon 4D™ Abutment Block has the same intended use and similar indications for use compared to the predicate, CEREC Tessera Abutment Block, CEREC Tessera Abutment System (K221402) and reference device Sirona Dental CAD/CAM System (inCoris ZI meso material) (K111421) in that they are used with TiBases, Implant Systems and CAD/CAM technology. The main difference is the compatible Implant systems and titanium bases. The block material and TiBase make up an a 2-piece hybrid abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. Table 6.2 compare the Intended Use and Indications for Use when compared to the predicate and reference devices. | Table 6.1-Comparison of Intended Use | | | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | CEREC Cercon 4D™ Abutment<br>Blocks, CEREC Cercon 4DTM<br>Abutment System (K234018) | Predicate Device<br>CEREC Tessera Abutment Block,<br>CEREC Tessera Abutment System<br>(K221402) | Reference Device<br>Sirona Dental CAD/CAM System<br>(inCoris ZI meso material)<br>(K111421) | Discussion | | | CEREC Cercon 4D™ Abutment<br>Blocks are a ceramic intended for<br>fixed dental prosthetic restorations. | CEREC Tessera Abutment Blocks are a<br>ceramic intended for fixed dental<br>prosthetic restorations. | inCoris ZI meso blocks are intended for use<br>in manufacturing individually designed<br>mesostructures, which are glued to a fitting<br>titanium base after milling and sintering. | The proposed and predicate<br>device have the same Intended<br>Use.<br>The Intended Use of the<br>reference device is similar to<br>Intended Use of the proposed<br>and predicate devices in that the<br>mesostructure is cemented to the<br>titanium base as part of a two-<br>piece hybrid abutment. | | | Table 6.2 - Comparison of Indications for Use | | | | | | CEREC Cercon 4D™ Abutment<br>Blocks, CEREC Cercon 4DTM<br>Abutment System (K234018) | Predicate Device<br>CEREC Tessera Abutment Block,<br>CEREC Tessera Abutment System<br>(K221402) | Reference Device<br>Sirona Dental CAD/CAM System<br>(inCoris ZI meso material)<br>(K111421) | Discussion | | | CEREC Cercon 4D™ Abutment<br>System is intended for use in<br>partially or fully edentulous<br>mandibles and maxillae in support<br>of single cement-retained<br>restorations.<br>The system comprises three parts:<br>• CEREC Cercon 4D™ Abutment<br>Block<br>• TiBases<br>• CAD/CAM system | CEREC Tessera Abutment System is<br>intended for use in partially or fully<br>edentulous mandibles and maxillae in<br>support of single cement-retained<br>restorations.<br>The system comprises three parts:<br>- CEREC Tessera Abutment Block<br>- TiBase<br>- CAD/CAM system | The Sirona Dental CAD/CAM System is<br>intended for use in partially or fully<br>edentulous mandibles and maxillae in<br>support of single or multiple-unit cement<br>retained restorations. The system consists of<br>three major parts: TiBase, InCoris<br>mesostructure, and CAD/CAM software. | Same as predicate and<br>reference devices.<br>The reference device is<br>additionally indicated for<br>multiple-unit cement<br>retained restorations which<br>pertains to other materials<br>used within the CAD/CAM<br>system. | | | The CEREC Cercon 4D™ ceramic<br>structure cemented to the TiBase is<br>recommended for two-piece hybrid<br>abutments for single tooth<br>restorations and hybrid abutment<br>crowns, used in conjunction with<br>endosseous dental implants. | The CEREC Tessera ceramic structure<br>cemented to the TiBase is recommended for<br>two-piece hybrid abutments for single tooth<br>restorations and hybrid abutment crowns,<br>used in conjunction with endosseous dental<br>implants. | Specifically, the InCoris mesostructure and<br>TiBase components make up a two-piece<br>abutment which is used in conjunction with<br>endosseous dental implants to restore the<br>function and aesthetics in the oral cavity. The<br>InCoris mesostructure may also be used in<br>conjunction with the Camlog Titanium base<br>CAD/CAM (types K2244.xxxx) (K083496)<br>in the Camlog Implant System. The<br>CAD/CAM software is intended to design<br>and fabricate the InCoris mesostructure. | The proposed and predicate<br>devices are the same.<br>The reference device is<br>similar with an additional<br>use with Camlog Implant<br>System and Titanium base.<br>The proposed block is also<br>indicated for use with the<br>Camlog (3rd party products).<br>Fatigue testing to support the<br>use with 3rd party implant<br>systems and TiBases is<br>included in the Performance<br>Bench Testing section. | | | Table 6.2 - Comparison of Indications for Use | | | | | | CEREC Cercon 4D™ Abutment<br>Blocks, CEREC Cercon 4D™<br>Abutment System (K234018) | Predicate Device<br>CEREC Tessera Abutment Block,<br>CEREC Tessera Abutment System<br>(K221402) | Reference Device<br>Sirona Dental CAD/CAM System<br>(inCoris ZI meso material)<br>(K111421) | Discussion | | | Implant Systems:<br>• Dentsply Sirona: PrimeTaper EV,<br>OmniTaper EV, AstraTech<br>OsseoSpeed TX, Frialit / XiVE,<br>AstraTech Implant EV, Ankylos<br>• BioHorizons: Internal connection<br>• Nobel Biocare: Replace, Replace<br>Select, Nobel Active,<br>NobelReplace Conical<br>Connection , Brånemark,<br>NobelSpeedy Groovy<br>• Straumann: Tissue Level, Bone<br>Level<br>• Thommen Medical: Element,<br>Contact<br>• Osstem/Hiossen: Osstem TS<br>, USA:Hiossen ET<br>• Zimmer/Biomet: External hex,<br>Certain, Tapered Screw-Vent<br>• MIS: C1 Conical<br>Connection, V3 Conical<br>Connection, SEVEN | The compatible Implant systems, titanium<br>bases and CAD/CAM systems are shown<br>below:<br>Implant Systems:<br>• Dentsply Sirona: AstraTech OsseoSpeed<br>TX (K053384), XiVE (K013867),<br>AstraTech Implant EV (K120414),<br>Ankylos (K083805), PrimeTaper EV<br>(K210610)<br>• MIS: C1 Conical connection (K172505<br>NP, K180282 WP), V3 Conical connection<br>(K163349), SEVEN internal hex<br>(K112162), M4 internal hex (K112162)<br>CAD/CAM Systems:<br>• Sirona Dental CAD/CAM System<br>(K193408, K200191)<br>Titanium Bases:<br>• Refer to Table 6.2a for the<br>compatible Titanium Bases | The InCoris mesostructure and TiBase two-<br>piece abutment is compatible with the<br>following implant systems:<br>• Nobel Biocare Replace (K020646)<br>• Nobel Biocare Branemark (K022562)<br>• Friadent Xive (K001386)<br>• Biomet 3i Osseotite (K980549)<br>• Astra Tech Osseospeed (K091239)<br>• Zimmer Tapered Screw-Vent (K061410)<br>• Straumann SynOcta (K061176)<br>• Straumann Bone Level (K053088)<br>• Biomet 3i Certain (K014235)<br>• Nobel Biocare Active (K071370) | Proposed device does not<br>include implant system or<br>titanium bases in the<br>Indications for Use<br>statement. Instead, a<br>compatibility table for the<br>Implant Systems and<br>TiBases is included within<br>the Instructions for Use<br>(IFU). | | | Table 6.2 - Comparison of Indications for Use | | | | | | CEREC Cercon 4D™ Abutment<br>Blocks, CEREC Cercon 4D™<br>Abutment System (K234018) | Predicate Device<br>CEREC Tessera Abutment Block,<br>CEREC Tessera Abutment System<br>(K221402) | Reference Device<br>Sirona Dental CAD/CAM System<br>(inCoris ZI meso material)<br>(K111421) | Discussion | | | internal hex, M4 internal hex | | | | | | • Altatec – Camlog | | | | | | CAD/CAM Systems: | | | | | | • Sirona Dental CAD/CAM System | | | | | | Refer to compatible Titanium Bases | | | | | | and Implant Systems Table above | | | | | | in the Indications for Use-Section 5. | | | | | | Table 6.2a- Compatibility Table included in the Predicate Device Indications for Use Statement above |…