# K213961: TruAbutment DS, TruBase

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Jul 14, 2022 after 206 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: 20 generations back to K894844 (1990). 211 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203649: TruAbutment DS, TruBase, Truabutment, Inc. (2021) Summary page 5.

## Most influential descendants
- 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: • Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) 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. TruBase 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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: • Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular) • Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm • BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0, 3.4, 3.8, 4.6, 5.8 mm • Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm 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/K213961
Methodology: https://510kreport.com/methodology