# K222778: Osstem Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 23, 2023 after 374 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). 54 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161604: OSSTEM Implant System, Osstem Implant Co., Ltd. (2016) Summary page 4.
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K163557: SS SA Fixture, Osstem Implant Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K242753: SD TL Implant System (2025), 1 descendant of its own
- K250280: SD TL Implant System (2025), 0 descendants of its own

## Indications for use
The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region. Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

Source page: https://510kreport.com/device/K222778
Methodology: https://510kreport.com/methodology