# K161103: US SA Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Feb 2, 2017 after 289 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: 13 generations back to K894595 (1990). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 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 4.
- K121995: TS Fixture System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K123755: Multi Angled Abutment, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K140934: Hiossen Implant System, Hiossen, Inc. (2014) Summary page 4.

## Indications for use
The US SA 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 bridges, or overdenture.

Source page: https://510kreport.com/device/K161103
Methodology: https://510kreport.com/methodology