# K202579: TruAbutment DS, TruBase

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jul 8, 2021 after 303 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: 18 generations back to K894844 (1990). 209 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201197: TruAbutment DS, TruBase S, Truabutment, Inc. (2021). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- 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 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 Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.58, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large) * Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular) * PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) + Straumann 2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC) + Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC) 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. TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific 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: • Astra Tech Implant System (KlOl732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large) • Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular) • PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) • Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (Kl62890): 2.9 (SC) • Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC) • Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5) All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

Source page: https://510kreport.com/device/K202579
Methodology: https://510kreport.com/methodology