# K110308: Prosthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Oct 3, 2011 after 243 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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). 27 ancestors in all.
105 later devices descend from it; 7 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 1.
- K100245: HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K120847: ET/SS Implant System (2012), 75 descendants of its own
- K123755: Multi Angled Abutment (2013), 47 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
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K110308
Methodology: https://510kreport.com/methodology