# K201197: TruAbutment DS, TruBase S

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Mar 26, 2021 after 326 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: 17 generations back to K894844 (1990). 208 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 215 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 7.
- K171532: TruBase S, Truabutment, Inc. (2018) Summary page 7.

## Most influential descendants
- K202579: TruAbutment DS, TruBase (2021), 4 descendants of its own
- K203649: TruAbutment DS, TruBase (2021), 3 descendants of its own
- K213961: TruAbutment DS, TruBase (2022), 1 descendant of its own
- K241485: TruAbutment DS; TruBase (2024), 0 descendants of its own
- K231210: DGA Abutment (2024), 0 descendants of its own

## Indications for use
TruAbutment DS 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 3.1mmD Dental Implant System (K142082) • Screw Vent® and Tapered Screw Vent® (K013227) • Nobel Active 3.0 (K102436) • Nobel Active Internal Connection Implant (K071370) 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. TruAbutment DS is compatible with the following devices: Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex Nobel Active 3.0 (K102436) Implant Body Diameter 3.0/ Implant Platform Diameter 3.0 / Internal Hex Nobel Active Internal Connection Implant (K071370) Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex TruBase S TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: • Zimmer 3.1mmD Dental Implant System (K142082) • Screw Vent® and Tapered Screw Vent® (K013227) TruBase S is intended to be sent to a TruAbutment-validated milling center for manufacture. TruBase S is compatible with the following devices: Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex

Source page: https://510kreport.com/device/K201197
Methodology: https://510kreport.com/methodology