# K183106: TruAbutment DS

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jan 29, 2020 after 447 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: 15 generations back to K894595 (1990). 32 ancestors in all.
7 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)
- K172304: TruAbutment DS, Truabutment, Inc. (2018) Summary page 4.

## Most influential descendants
- 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
- K243255: URIS Long Implant & Abutments (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. [t is compatible with the following systems: * Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm * BioHorizons Laser-Lok Implant System (K093321) 3.0 mm The available range of diameters is summarized below: Tapered Internal / Laser-Lok 3.0 Implant @ (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal Implant @ (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Implant @ (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant @ (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex Implant @ (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex 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/K183106
Methodology: https://510kreport.com/methodology