# K221684: Osstem Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 8, 2022 after 90 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894595 (1990). 230 ancestors in all.
No later device cites it as a predicate yet.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182091: Osstem Abutment System, Osstem Implant Co., Ltd. (2019) Summary page 4.
- K160670: ET US SS Prosthetic system, Osstem Implant Co., Ltd. (2017) Summary page 4.

## Indications for use
The OSSTEM Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K221684
Methodology: https://510kreport.com/methodology