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    K Number
    K252248

    Validate with FDA (Live)

    Device Name
    CEREC Tessera Abutment System
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2025-11-26

    (131 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K234018,K250295,K111421,K143022,K071638,K093321,K042429,K020646,K071370,K022562,K151324,K192742,K093615,K090154,K121585,K061410,K061629,K014235,K083496,K191152,K200191,K193408,K181520,K100152,K221402
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CEREC Tessera Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

    For BH 3.0 S, NC Variobase C 3.3, Camlog 3.3 S and S BL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

    The system comprises three parts:

    • CEREC Tessera Abutment Block
    • TiBase
    • CAD/CAM system

    The CEREC Tessera 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.

    The compatible Implant systems, titanium bases and CAD/CAM systems are shown below:

    Implant Systems:

    • Dentsply Sirona: Astra Tech OsseoSpeed TX, Ankylos
    • BioHorizons: Internal connection
    • Nobel Biocare: Replace, Replace Select, Nobel Active, NobelReplace Concial Connection, Branemark, 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
    • MIS: C1 Conical connection (NP and WP), V3 Conical connection, SEVEN internal hex, M4 internal hex

    CAD/CAM Systems:

    • Sirona Dental CAD/CAM System

    Titanium Bases:

    Implant: AstraTech Osseospeed TX

    • Platform: 3.5/4.0; TiBase AT TX 3.5/4.0 GH1 L; Reference 6598093; Size L
    • Platform: 4.5/5.0; TiBase AT TX 4.5/5.0 GH1 L; Reference 6598101; Size L
    • Platform: 3.5/4.0; TiBase AT OS 3.5/4.0 GH1 L; Reference 6282532; Size L
    • Platform: 4.5/5.0; TiBase ATOS 4.5/5.0 GH1 L; Reference 6282540; Size L

    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: M.I.S. Implants

    Implant: C1 Conical Connection

    • Platform: NP; CN-TB001 C1 NP GH 0.5; Reference CN-TB001; Size: L
    • Platform: NP; CN-B015 C1 NP GH 1.5; Reference CN-TB015; Size: L

    Implant: V3 Conical Connection

    • Platform: NP; VN-TB001 V3 NP GH 0.5; Reference VN-TB001; Size: L
    • Platform: NP; VN-TB015 V3 NP GH 1.5; Reference VN-TB015; Size: L

    Implant: V3 Conical Connection / C1 Conical Connection

    • Platform: SP; CS-TB001 SP GH 0.5; Reference CS-TB001; Size: L
    • Platform: SP; CS-TB015 SP GH 1.5; Reference CS-TB015; Size: L
    • Platform: SP; CS-TB030 SP GH 3; Reference CS-TB030; Size: L

    Implant: C1 Conical Connection

    • Platform: WP; CW-TB001 C1 WP GH 0.5; Reference CW-TB001; Size: L
    • Platform: WP; CW-TB015 C1 WP GH 1.5; Reference CW-TB015; Size: L
    • Platform: WP; CW-TB030 C1 WP GH 3; Reference CW-TB030; Size: L

    Implant: SEVEN internal hex, M4 internal hex

    • Platform: NP; MN-TB001 INT HEX NP GH 0.5; Reference MN-TB001; Size: L
    • Platform: NP; MN-TBC15 INT HEX NP GH 1.5; Reference MN-TBC15; Size: L
    • Platform: SP; MD-TB001 INT HEX SP GH 0.5; Reference MD-TB001; Size: L
    • Platform: SP; MD-TBC15 INT HEX SP GH 1.5; Reference MD-TBC15; Size: L
    • Platform: SP; MD-TBC30 INT HEX SP GH 3; Reference MD-TBC30; Size: L
    • Platform: WP; MW-TB001 INT HEX WP GH 0.5; Reference MW-TB001; Size: L
    • Platform: WP; MW-TBC15 INT HEX WP GH 1.5; Reference: MW-TBC15; Size: L
    • Platform: WP; MW-TBC30 INT HEX WP GH 3; Reference: MW-TBC30; Size: L

    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, Nobel Replace Conical Connection

    • Platform: NP; TiBase NB A 4.5 GH 1 L; Reference 6308188; Size: L
    • Platform: RP; TiBase NB A 5.0 GH 1 L; Reference 6308253; Size: L

    Implant: Branemark

    • 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
    • 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 BO 3.4 GH 1 L; Reference 6282557; Size: L
    • Platform: 4.1; TiBase BO 4.1 GH 1 L; Reference 6282565; Size: L
    • Platform: 5.0; TiBase BO 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 BC 4.1 GH 1 L; Reference 6308097; Size: L
    • Platform: 5.0; TiBase BC 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: Straumann

    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 CAD/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
    Device Description

    The proposed CEREC Tessera Abutment System is a modification of the previously cleared CEREC Tessera Abutment Block (K221402). The proposed CEREC Tessera Abutment Blocks are intended for fabrication of single cement-retained restorations. The proposed CEREC Tessera Abutment System (with the additional TiBase and Implant System compatibilities and change in wall thickness) is comprised of the CEREC Tessera Abutment Block, applicable TiBase, and CAD/CAM systems in both chairside (CEREC chairside software) and labside (inLab labside software) use. The CEREC Tessera Abutment Blocks are not provided as the finished, fully assembled dental implant medical device. The CEREC Tessera 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.

    The CEREC Tessera Abutment Blocks are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure used to create 2-piece hybrid abutments and hybrid abutment crowns cemented to a TiBase used with dental implant systems. The patient-specific ceramic structure is then cemented to a TiBase to create the two-piece abutment which constitutes the final finished medical device. The following patient-specific ranges for CAD/CAM fabrication of the abutments are:

    • Maximum angulation of 20°
    • Minimal wall thickness of 0.5 mm
    • Gingival height ranges from 0.5 mm -3.0 mm
    • Minimum abutment post height (i.e. length above the gingival height) of >4 mm
    AI/ML Overview

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