# K101096: HT Iii SA Fixture System

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: Oct 8, 2010 after 171 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: 10 generations back to K894595 (1990). 31 ancestors in all.
104 later devices descend from it; 7 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093352: HG Iii Fixture System, Hiossen, Inc. (2009) Summary page 1.
- K061176: Straumann Dental Implants, Institut Straumann AG (2006) Summary page 1.

## Most influential descendants
- K120847: ET/SS Implant System (2012), 75 descendants of its own
- K121585: TS Implant System (2013), 64 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own
- K130662: ET Prosthetic System (2014), 42 descendants of its own
- K161689: OSSTEM Implant System - Abutment (2017), 38 descendants of its own

## Indications for use
The HT III SA Fixture 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 terminal or intermediate abutment support for fixed bridgework. The HT III SA Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K101096
Methodology: https://510kreport.com/methodology