# K120089: Biogenesis Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biogenesis Co., Ltd.
- Decided: Mar 13, 2013 after 427 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: 10 generations back to K960026 (1996). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082213: GS Iii Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K051614: Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics, Lifecore Biomedical, Inc. (2005) Summary page 1.
- K052823: Implantium Abutments, Dentium, Inc. (2006) Summary page 1.
- K070562: EZ Plus Implant System, Megagen Co., Ltd. (2007) Summary page 1.

## Indications for use
The Biogenesis Implant System - Aticon is indicated for use in partially or flly edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Source page: https://510kreport.com/device/K120089
Methodology: https://510kreport.com/methodology