# K120847: ET/SS Implant System

- Pathway: 510(k) (Special)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 10, 2012 after 143 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: 11 generations back to K894595 (1990). 45 ancestors in all.
75 later devices descend from it; 11 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080387: HU II / HS II Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K101096: HT Iii SA Fixture System, Hiossen, Inc. (2010) Summary page 1.
- K083633: HS II Short Fixture System, Osstem Implant Co., Ltd. (2009) Summary page 1.
- K110308: Prosthetic System, Osstem Implant Co., Ltd. (2011)
- K081786: Ziocera & Convertible System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K130662: ET Prosthetic System (2014), 42 descendants of its own
- K161689: OSSTEM Implant System - Abutment (2017), 38 descendants of its own
- K160670: ET US SS Prosthetic system (2017), 32 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K142313: OneQ-SL Implant System (2015), 19 descendants of its own

## Indications for use
The ET/SS Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

Source page: https://510kreport.com/device/K120847
Methodology: https://510kreport.com/methodology