# K964330: Biohorizons Dental Implant System (Name Subject to Change)

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jan 17, 1997 after 78 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
Longest line of descent: 1 generation back to K960026 (1996). 1 ancestor in all.
337 later devices descend from it; 6 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)
- K960026: Biohorizons Dental Implant System, BioHorizons Implant Systems, Inc. (1996) Summary page 2.
- (no number) Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants: named in the summary without a submission number

## Most influential descendants
- 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
- K030463: Modification to the Maestro System (2003), 331 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/K964330
Methodology: https://510kreport.com/methodology