# K203649: TruAbutment DS, TruBase

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Sep 15, 2021 after 275 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: 19 generations back to K894844 (1990). 210 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K202579: TruAbutment DS, TruBase, Truabutment, Inc. (2021). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- 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: • MIS Cl Conical Connection Implant (Kl 72505, Kl 12162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) • Neodent Implant System - GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) • Nobel Biocare Groovy Implants (K050258) : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) • Straumann BLX Implant (Kl 73961, K181703, K191256) : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) • Straumann Tissue Level Implant (Kl 11357) : 3.3(NNC) 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 screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: • MIS Cl Conical Connection Implant (Kl72505, Kl12162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) • Neodent Implant System - GM Helix (K163194, Kl80536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) • Nobel Biocare Groovy Implants (K050258) : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) • Straumann BLX Implant (Kl73961, Kl81703, K191256) : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) • Straumann Tissue Level Implant (Kl11357) : 3.3(NNC) 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/K203649
Methodology: https://510kreport.com/methodology