# K142813: Biogensis Implant System-Kisses

- Pathway: 510(k) (Traditional)
- Applicant: Biogenesis Co., Ltd.
- Decided: Jul 31, 2015 after 305 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: 13 generations back to K894595 (1990). 47 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
The Biogenesis Implant System - Kisses is indicated for use in partially or fully 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/K142813
Methodology: https://510kreport.com/methodology