# K241485: TruAbutment DS; TruBase

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Oct 9, 2024 after 138 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.
No later device cites it as a predicate yet.
0 of 212 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 7.

## Indications for use
TruAbutment DS TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: • Astra OsseoSpeed EV (K130999, K120414) : 3.0, 3.6, 4.2, 4.8, 5.4 mm. • Biomet 3i Full OSSEOTITE Tapered 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 (Narrow, Regular) mm. • Neoss ProActive® (K083561) : 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. • Osstem TS (K161604) : 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) mm. • Camlog Screw-Line (K083496) : 3.3, 3.8, 4.3, 5.0, 6.0 mm. • Conelog Screw-Line (K113779) : 3.3, 3.8, 4.3, 5.0 mm. • Implant Direct Legacy2 (K192221) : 3.2 mm. • BioHorizons Internal Implant System (K093321, K143022, K071638) : 3.0, 3.4, 3.8, 4.6, 5.8 mm. • MegaGen AnyRidge Internal Implant (K140091) : 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm. All digitally designed abutments and/or copings 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: • Astra OsseoSpeed EV (K130999): 3.0 mm. • Biomet 3i Full OSSEOTITE Tapered 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 (Narrow, Regular) mm. • Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm. • Camlog Screw-Line (K083496): 3.3, 3.8, 4.3, 5.0, 6.0 mm. • Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm. • Implant Direct Legacy2 (K192221): 3.2 mm. All digitally designed abutments and/or copings 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/K241485
Methodology: https://510kreport.com/methodology