# K053152: Biohorizons Single-Stage Implant

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Dec 2, 2005 after 22 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960026 (1996). 10 ancestors in all.
77 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020645: Modification to the Maestro System, BioHorizons Implant Systems, Inc. (2002) Summary page 1.
- K042429: The Prodigy System Dental Implants, BioHorizons Implant Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K073282: Biohorizons Single-Stage Implant System (2008), 76 descendants of its own
- K100985: Biohorizons Simple Solutions with Laser-Lok (2010), 73 descendants of its own
- K103691: Biohorizons Abutments for Zimmer (2011), 45 descendants of its own
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K103291: Biohorizons Laser-Lok Abutments for Nobel Biocare (2011), 30 descendants of its own

## Recalls of this device
- Sep 7, 2010 · Not classified · Z-0321-2011: Healing abutment may not fully seat on the implant.

## Indications for use
The BioHorizons Single-stage implant 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/K053152
Methodology: https://510kreport.com/methodology