# K073268: Biohorizons Internal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Feb 8, 2008 after 80 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). 11 ancestors in all.
111 later devices descend from it; 8 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042429: The Prodigy System Dental Implants, BioHorizons Implant Systems, Inc. (2004) Summary page 1.
- K071638: Biohorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K093321: Biohorizons Laser-Lok 3.0 Implant System (2010), 103 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
- Oct 30, 2015 · Class II · Z-0391-2016: An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

## Indications for use
BioHorizons Internal Implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or for fixed bridgework and dental retention. BioHorizons Internal Implants may be restored immediately with a temporary prosthesis that is not in functional occlusion, or when splinted together for multiple tooth replacement, or when stabilized with an overdenture supported by multiple implants.

Source page: https://510kreport.com/device/K073268
Methodology: https://510kreport.com/methodology