# K093889: Modification to: HG Iii Ultra Wide System

- Pathway: 510(k) (Special)
- Applicant: Hiossen, Inc.
- Decided: Apr 22, 2010 after 125 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: 8 generations back to K894595 (1990). 19 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073465: US/GS Ultra Wide System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K103537: ET Iii SA Ultra Wide System (2011), 37 descendants of its own
- K121995: TS Fixture System (2012), 24 descendants of its own
- K140934: Hiossen Implant System (2014), 13 descendants of its own
- K153521: IH Implant System (2016), 10 descendants of its own
- K151626: ET III Bio-SA Fixture System (2016), 9 descendants of its own

## Indications for use
The HGIII Ultra wide 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 Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The HGIII Ultra wide Fixture System is intended to be used in the molar region.

Source page: https://510kreport.com/device/K093889
Methodology: https://510kreport.com/methodology