# K152559: TruAbutment DS

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment
- Decided: May 20, 2016 after 254 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 K894595 (1990). 29 ancestors in all.
18 later devices descend from it; 1 cites 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)
- K123627: ET Smartfit Abutment, Hiossen, Inc. (2013) Summary page 6.

## Most influential descendants
- K170259: TruAbutment DS (2017), 17 descendants of its own
- 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

## Indications for use
The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes. 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/K152559
Methodology: https://510kreport.com/methodology