# K103339: TDS Abutment for Friadent Xive

- Pathway: 510(k) (Traditional)
- Applicant: Pou YU Biotechnology Co., Ltd.
- Decided: Mar 31, 2011 after 136 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: 11 generations back to K960026 (1996). 125 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032302: Xive TG Abutments, Friadent GmbH (2003) Summary page 1.
- K072241: Primaconnex Cad/Cam Abutment System, Lifecore Biomedical, Inc. (2007) Summary page 1.
- K063734: Atlantis Abutment in Zirconia for 3I Certain Interface, Atlantis Components, Inc. (2007) Summary page 1.

## Most influential descendants
- K150296: Biodenta Customized Abutment-Hybrid (2015), 0 descendants of its own
- K131468: Denracle Dental Abutment (2014), 0 descendants of its own
- K121117: NDX Abutments (2012), 0 descendants of its own

## Indications for use
TDS Abutment for Friadent Xive 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 internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseoispeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok®& 3.0 implant system; Lifecore:,Lifecore RENOVATM Internal Hex Implant System; Zimimer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.

Source page: https://510kreport.com/device/K103339
Methodology: https://510kreport.com/methodology