# K140507: Hiossen Prosthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 20, 2014 after 174 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: 12 generations back to K894595 (1990). 68 ancestors in all.
44 later devices descend from it; 6 cite it directly.
0 of 113 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 4.
- K121585: TS Implant System, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K121843: NP-Cast Abutment System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K110308: Prosthetic System, Osstem Implant Co., Ltd. (2011) Summary page 4.
- K073247: US/SS/GS System, Osstem Implant Co., Ltd. (2008) Summary page 4.

## Most influential descendants
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K153521: IH Implant System (2016), 10 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K172100: URIS OMNI System (2018), 7 descendants of its own

## Indications for use
Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

Source page: https://510kreport.com/device/K140507
Methodology: https://510kreport.com/methodology