# Truabutment, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 17 (2016–2025): 17 510(k) clearances
- Names in FDA's records: Truabutment, Inc. (15); Truabutment (2)
- Product codes: NHA (13), DZE (4)
- 510(k) review time since 2016: median 275 days, against 200 for FDA's reviews in the same codes and years (5 of 17 faster)
- Predicates its devices cite: 38 (18 its own); citations of its devices by later devices: 21 (18 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Osstem Implant Co., Ltd.: 10 (https://510kreport.com/company/osstem-implant)
- Warantec Co., Ltd.: 2 (https://510kreport.com/company/warantec)
- Straumann USA: 2 (https://510kreport.com/company/straumann-usa)
- Megagen Implant Co., Ltd.: 1 (https://510kreport.com/company/megagen-implant)
- Preat Corporation: 1 (https://510kreport.com/company/preat)
- Southern Implants (Pty), Ltd.: 1 (https://510kreport.com/company/southern-implants)
- Hiossen, Inc.: 1 (https://510kreport.com/company/hiossen)
- Neobiotech Co., Ltd.: 1 (https://510kreport.com/company/neobiotech)

## Firms that cite its devices most
- Cowellmedi Co., Ltd.: 2 (https://510kreport.com/company/cowellmedi)
- Modern Dental Laboratory (Dg) Co., Ltd.: 1 (https://510kreport.com/company/modern-dental-laboratory-dg)

## Its most-cited devices
- K200817: URIS OMNI Narrow System & Prosthetic (2020), cited by 5
- K170259: TruAbutment DS (2017), cited by 3
- K172100: URIS OMNI System (2018), cited by 3
- K203649: TruAbutment DS, TruBase (2021), cited by 2
- K201197: TruAbutment DS, TruBase S (2021), cited by 2
- K171532: TruBase S (2018), cited by 1

## Recent decisions
- K243255: URIS Long Implant & Abutments (Jul 3, 2025)
- K241485: TruAbutment DS; TruBase (Oct 9, 2024)
- K230438: URIS Smart Path Implant System & Prosthetic (Dec 29, 2023)
- K231874: AOT & T-L Abutment (Oct 30, 2023)
- K213961: TruAbutment DS, TruBase (Jul 14, 2022)
- K203649: TruAbutment DS, TruBase (Sep 15, 2021)
- K202579: TruAbutment DS, TruBase (Jul 8, 2021)
- K201842: TruBase S (Jun 4, 2021)

Source page: https://510kreport.com/company/truabutment