# K172304: TruAbutment DS

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jan 23, 2018 after 176 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: 14 generations back to K894595 (1990). 31 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170259: TruAbutment DS, Truabutment (2017) Summary page 4.

## Most influential descendants
- K183106: TruAbutment DS (2020), 7 descendants of its own
- K200817: URIS OMNI Narrow System & Prosthetic (2020), 6 descendants of its own
- K231411: INNO SLA Submerged Hybrid Ti-Base System (2023), 1 descendant of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 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: « Astra Tech OsseoSpeed™ EV 3.0, 3.6, 4.2, 4.8, 5.4 mm * Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm » Straumann® Bone Level Implants 3.3, 4.1, 4.8 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/K172304
Methodology: https://510kreport.com/methodology