# K252248: CEREC Tessera Abutment System - Pathway: 510(k) (Traditional) - Applicant: Dentsply Sirona - Decided: Nov 26, 2025 after 131 days - Product code: NHA (Abutment, Implant, Dental, Endosseous) - Device class: 2 - Regulation: 21 CFR 872.3630 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 14 generations back to K894844 (1990). 126 ancestors in all. No later device cites it as a predicate yet. 0 of 127 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K221402: CEREC Tessera Abutment Block, CEREC Tessera Abutment System, Dentsply Sirona, Inc. (2023) Summary page 8. ## Indications for 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 Siron a: AstraTech 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 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: Tapere d 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 0 3.3 mm GH 0.4; Refere nce K2244.3348; Size S Platform: 3.8; CAMLOG Titanium Base CAD/CAM, for 0 3.8 mm GH 0.3; Reference K2244.3848; Size: S Platform: 4.3; CAMLOG Titanium Base CAD/CAM, for 0 4.3 mm GH 0.3; Reference K2244.4348; Size: S Platform: 6.0; CAMLOG Titanium Base CAD/CAM, for 0 6.0 mm GH 0.3; Reference 1<2244.6048; Size: L Source page: https://510kreport.com/device/K252248 Methodology: https://510kreport.com/methodology