# K191913: TruAbutment DS

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jun 19, 2020 after 338 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.
No later device cites it as a predicate yet.
0 of 32 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 5.

## 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: • Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm • DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm • Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm • Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm The available range of diameters is summarized below: Biomet 3i Certain® (K130949) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.4 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 5.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 6.0 / Type of Implant-Abutment Connection : Internal Hex DIO UF(II) Internal Submerged (K161987, K170608, K173975) Implant Ø (mm) : 3.3 / Implant Platform (mm) : Narrow / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.8 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : Regular / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.5 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 7.0 / Implant Platform (mm) : Wide / Type of Implant-Abutment Connection : Internal Hex Megagen AnyRidge® (K140091) Implant Ø (mm) : 3.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 3.1 / Type of Implant-Abutment Connection : Internal Hex Neoss ProActive® (K083561) Implant Ø (mm) : 3.25 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 3.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 4.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.0 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 5.5 / Implant Platform (mm) : 4.0 / Type of Implant-Abutment Connection : Internal Hex Implant Ø (mm) : 6.0 / Implant Platform (mm) : 4.0 / 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/K191913
Methodology: https://510kreport.com/methodology