# K160519: Link Abutment for CEREC

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Oct 28, 2016 after 246 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: 16 generations back to K894844 (1990). 213 ancestors in all.
No later device cites it as a predicate yet.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120847: ET/SS Implant System, Osstem Implant Co., Ltd. (2012) Summary page 4.
- K151324: Straumann Variobase for CEREC, Straumann USA, LLC (2015) Summary page 4.

## Indications for use
The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN 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. Link abutment for CEREC 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/K160519
Methodology: https://510kreport.com/methodology