# K234018: CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: May 7, 2024 after 139 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 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, 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

Source page: https://510kreport.com/device/K234018
Methodology: https://510kreport.com/methodology