# K061567: Biohorizons Ceramic Abutment

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Nov 22, 2006 after 169 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: 8 generations back to K960026 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023631: Astra Tech Dental Implants-Ceramic Abutments, Astra Tech, Inc. (2002) Summary page 1.
- K042429: The Prodigy System Dental Implants, BioHorizons Implant Systems, Inc. (2004) Summary page 1.

## Indications for use
BioHorizons Ceramic Abutments are intended for use in the anterior esthetic zone with BioHorizons Dental Implant-supported prosthetic restorations. BioHorizons endosseous dental implants may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.

Source page: https://510kreport.com/device/K061567
Methodology: https://510kreport.com/methodology