# K091392: TDS Titanium Abutment for Nobel Biocare Branemark

- Pathway: 510(k) (Traditional)
- Applicant: Pou YU Biotechnology Co., Ltd.
- Decided: Jul 30, 2009 after 80 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K110778: Biodenta Customized Abutment (2011), 2 descendants of its own
- K151295: Biodenta Customized Abutment - Titanium (2015), 1 descendant of its own
- K231210: DGA Abutment (2024), 0 descendants of its own
- K121117: NDX Abutments (2012), 0 descendants of its own

## Indications for use
TDS Titanium Abutment for Nobel Biocare Branemark 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. This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

Source page: https://510kreport.com/device/K091392
Methodology: https://510kreport.com/methodology