# K170259: TruAbutment DS

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment
- Decided: May 25, 2017 after 118 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: 13 generations back to K894595 (1990). 30 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152559: TruAbutment DS, Truabutment (2016) Summary page 5.

## Most influential descendants
- K172304: TruAbutment DS (2018), 8 descendants of its own
- K183106: TruAbutment DS (2020), 7 descendants of its own
- K201197: TruAbutment DS, TruBase S (2021), 6 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K202579: TruAbutment DS, TruBase (2021), 4 descendants of its own

## Indications for use
The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: » Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

Source page: https://510kreport.com/device/K170259
Methodology: https://510kreport.com/methodology