# K081460: TDS Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Pou YU Biotechnology Co., Ltd.
- Decided: Nov 21, 2008 after 182 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121117: NDX Abutments (2012), 0 descendants of its own

## Indications for use
TDS Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Source page: https://510kreport.com/device/K081460
Methodology: https://510kreport.com/methodology