# K161689: OSSTEM Implant System - Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: May 22, 2017 after 336 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 67 ancestors in all.
38 later devices descend from it; 13 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130662: ET Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 4.
- K081786: Ziocera & Convertible System, Osstem Implant Co., Ltd. (2008) Summary page 4.
- K121585: TS Implant System, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K100245: HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own

## Recalls of this device
- Jan 27, 2025 · Class II · Z-1276-2025: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as
- Jan 27, 2025 · Class II · Z-1274-2025: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as

## Indications for use
The OSSTEM Implant System - Abutment 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/K161689
Methodology: https://510kreport.com/methodology