# K221402: CEREC Tessera Abutment Block, CEREC Tessera Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Mar 22, 2023 after 310 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: 13 generations back to K894844 (1990). 125 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191382: IPS e.max CAD Abutment Solutions- extra systems, Ivoclar Vivadent, AG (2019) Summary page 6.

## Most influential descendants
- K252248: CEREC Tessera Abutment System (2025), 0 descendants of its own
- K234018: CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System (2024), 0 descendants of its own

## 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. 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: AstraTech OsseoSpeed TX (K053384), XiVE (K013867), AstraTech Implant EV (K120414), Ankylos (K083805), PrimeTaper EV (K210610) - MIS: C1 Conical connection (K172505 NP, K180282 WP), V3 Conical connection (K163349), SEVEN internal hex (K112162), M4 internal hex (K112162) CAD/CAM Systems: - Sirona Dental CAD/CAM System (K193408, K200191)

Source page: https://510kreport.com/device/K221402
Methodology: https://510kreport.com/methodology