# K131468: Denracle Dental Abutment

- Pathway: 510(k) (Abbreviated)
- Applicant: Green Dentech Co, Ltd.
- Decided: May 6, 2014 after 350 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 K960026 (1996). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103339: TDS Abutment for Friadent Xive, Pou YU Biotechnology Co., Ltd. (2011) Summary page 1.

## Indications for use
Denracle Dental Abutment for OSSTEM GS Implant is intended for use with dental implant as a support for single or multiple tooth prostheses in maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system: OSSTEM GS Fixture System ø4.0mm ø4.5mm ø5.0mm

Source page: https://510kreport.com/device/K131468
Methodology: https://510kreport.com/methodology