# K231874: AOT & T-L Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Truabutment, Inc.
- Decided: Oct 30, 2023 after 126 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 K960026 (1996). 432 ancestors in all.
No later device cites it as a predicate yet.
0 of 433 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200817: URIS OMNI Narrow System & Prosthetic, Truabutment, Inc. (2020) Summary page 5.

## Indications for use
AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. It is compatible with the following systems: • Astra OsseoSpeed EV(K130999) 3.0 • Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm • Dentium Company Limited Implantium (K041368) 3.6, 4.0, 4.5, 5.0 (Regular) • Implant Direct Legacy2(K192221) 3.0 • Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1) • Neodent Implant System - GM Helix (K163194, Kl80536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0) • Nobel Active 3.0 (K102436) 3.0 • Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0 • Nobelactive Wide Platform (Wp) (K133731) WP 5.5 • TS Fixture System (K121995) 3.5 (3.75) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular) • Straumann BLX Implant (Kl73961, Kl81703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) • 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) • Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9) • Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

Source page: https://510kreport.com/device/K231874
Methodology: https://510kreport.com/methodology