# K233194: TS Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Feb 20, 2024 after 145 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). 231 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 234 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 5.
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 5.
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 5.
- K161604: OSSTEM Implant System, Osstem Implant Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K251434: Healing Abutment System (2026), 0 descendants of its own
- K251427: EK Multi Angled 30 Abutment (2026), 0 descendants of its own

## 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/K233194
Methodology: https://510kreport.com/methodology