# K121585: TS Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jan 7, 2013 after 221 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). 61 ancestors in all.
64 later devices descend from it; 8 cite it directly.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091678: HG II Short Fixture System, Osstem Implant Co., Ltd. (2010) Summary page 1.
- K101096: HT Iii SA Fixture System, Hiossen, Inc. (2010) Summary page 1.
- K100245: HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2010) Summary page 1.
- K072679: P.004 Abutments, Institut Straumann AG (2007) Summary page 1.
- K093027: Straumann RC Temporary Abutments, Straumann USA (2010) Summary page 1.

## Most influential descendants
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own
- K161689: OSSTEM Implant System - Abutment (2017), 38 descendants of its own
- K160670: ET US SS Prosthetic system (2017), 32 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K140934: Hiossen Implant System (2014), 13 descendants of its own

## Indications for use
The TS Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture. TS Implant System is compatible with abutment in the ET/SS Implant System

Source page: https://510kreport.com/device/K121585
Methodology: https://510kreport.com/methodology