# K103537: ET Iii SA Ultra Wide System

- Pathway: 510(k) (Special)
- Applicant: Hiossen, Inc.
- Decided: Mar 10, 2011 after 98 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). 37 ancestors in all.
37 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093889: Modification to: HG Iii Ultra Wide System, Hiossen, Inc. (2010) Summary page 1.
- K101096: HT Iii SA Fixture System, Hiossen, Inc. (2010) Summary page 1.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own

## Indications for use
The ETIII SA Ultra wide System is indicated for use in partially or fully edentulous mandibles and maxillac, in support of single or mnultiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIfi SA Ultra wide Fixture System is for single and two stage surgical procedures. It is not for immediate load. The ETIII SA Ultra wide Fixture System is intended to be used in thle molar region.

Source page: https://510kreport.com/device/K103537
Methodology: https://510kreport.com/methodology