# K182091: Osstem Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Jul 12, 2019 after 343 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: 14 generations back to K894595 (1990). 229 ancestors in all.
30 later devices descend from it; 11 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161689: OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K140507: Hiossen Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 4.
- K063861: GS System, Osstem Implant Co., Ltd. (2007) Summary page 4.
- K150295: LOCATOR RTx, Zest Anchors, Inc. (2015) Summary page 4.
- K132067: Multi Angled Abutment System, Hiossen, Inc. (2013) Summary page 4.
- K062030: US System, Osstem Implant Co., Ltd. (2006) Summary page 4.
- K160670: ET US SS Prosthetic system, Osstem Implant Co., Ltd. (2017) Summary page 4.
- K080594: MS System (Narrow Ridge), Osstem Implant Co., Ltd. (2008) Summary page 4.

## Most influential descendants
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K233194: TS Abutment System (2024), 2 descendants of its own
- K221866: S-Plant Dental Implant System (2024), 2 descendants of its own

## Indications for use
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. • Link Abutment for CEREC The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Source page: https://510kreport.com/device/K182091
Methodology: https://510kreport.com/methodology