# K960026: Biohorizons Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Mar 28, 1996 after 86 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
338 later devices descend from it; 7 cite it directly.
0 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants: named in the summary without a submission number
- (no number) Branemark System® Implants: named in the summary without a submission number

## Most influential descendants
- K964330: Biohorizons Dental Implant System (Name Subject to Change) (1997), 337 descendants of its own
- K972313: The Maestro System (1997), 336 descendants of its own
- K020133: Modification to the Maestro System (2002), 334 descendants of its own
- K020645: Modification to the Maestro System (2002), 333 descendants of its own
- K022795: Modification to the Maestro System (2002), 332 descendants of its own

## Indications for use
The BioHorizons Dental Implant System 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/K960026
Methodology: https://510kreport.com/methodology