# K073465: US/GS Ultra Wide System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Apr 7, 2008 after 119 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: 7 generations back to K894595 (1990). 18 ancestors in all.
90 later devices descend from it; 4 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 1.
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K090825: SQ IS System (2009), 55 descendants of its own
- K093889: Modification to: HG Iii Ultra Wide System (2010), 38 descendants of its own
- K103537: ET Iii SA Ultra Wide System (2011), 37 descendants of its own
- K113554: Cmi Implant IS System (2012), 34 descendants of its own
- K121995: TS Fixture System (2012), 24 descendants of its own

## Indications for use
The US/GS Ultra Wide 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 US/GS Ultra Wide System is for single and two stage surgical procedures. It is not for immediate load. The US/GS Ultra Wide System is intended to be used in the molar reoion.

Source page: https://510kreport.com/device/K073465
Methodology: https://510kreport.com/methodology