# K160670: ET US SS Prosthetic system

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Apr 25, 2017 after 411 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: 13 generations back to K894595 (1990). 74 ancestors in all.
32 later devices descend from it; 4 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 4.
- K121585: TS Implant System, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K100245: HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2010) Summary page 4.
- K130662: ET Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 4.
- K062051: SS System, Osstem Implant Co., Ltd. (2006) Summary page 4.
- K073247: US/SS/GS System, Osstem Implant Co., Ltd. (2008) Summary page 4.
- K121843: NP-Cast Abutment System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 4.
- K132067: Multi Angled Abutment System, Hiossen, Inc. (2013) 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
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K233194: TS Abutment System (2024), 2 descendants of its own

## Indications for use
ET System The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures. US/SS System The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

Source page: https://510kreport.com/device/K160670
Methodology: https://510kreport.com/methodology