# K093352: HG Iii Fixture System

- Pathway: 510(k) (Special)
- Applicant: Hiossen, Inc.
- Decided: Nov 24, 2009 after 28 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: 9 generations back to K894595 (1990). 20 ancestors in all.
105 later devices descend from it; 1 cites it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082213: GS Iii Fixture System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K101096: HT Iii SA Fixture System (2010), 104 descendants of its own
- 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

## Indications for use
The HGIII 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 HGIII Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Source page: https://510kreport.com/device/K093352
Methodology: https://510kreport.com/methodology