# K223814: Genesis ACTIVE Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Dental, Inc.
- Decided: May 25, 2023 after 156 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: 11 generations back to K960026 (1996). 123 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101545: Genesis Implant System, Keystone Dental (2010) Summary page 4.

## Most influential descendants
- K240966: Prima Plus Conical Implant System (2024), 0 descendants of its own

## Indications for use
The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Genesis ACTIVE Implant System implants are to be sent to a Keystone Dental validated milling center for manufacture. The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

Source page: https://510kreport.com/device/K223814
Methodology: https://510kreport.com/methodology