Manufacturer registered with FDA
TruAbutment Inc.
Irvine, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 172016–2025
- Markets registered in
- 531 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name TruAbutment Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | TruAbutment Inc. | 17 clearances | 2016–2025 | Below |
| Australia | TGA | Manufacturer | TruAbutment INC | 11 | 2024–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TruAbutment Inc. | 11 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TruAbutment Inc. | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TruAbutment Inc. | 3 | 2017–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What TruAbutment Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | TruAbutment DSTruAbutment DS, TruBase | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | T-Marker SW | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names TruAbutment Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Jul 2025 | K243255 | URIS Long Implant & Abutments | DZE Root-Form Endosseous Implant |
| 9 Oct 2024 | K241485 | TruAbutment DS; TruBase | NHA Endosseous Dental Implant Abutment |
| 29 Dec 2023 | K230438 | URIS Smart Path Implant System & Prosthetic | DZE Root-Form Endosseous Implant |
| 30 Oct 2023 | K231874 | AOT & T-L Abutment | NHA Endosseous Dental Implant Abutment |
| 14 Jul 2022 | K213961 | TruAbutment DS, TruBase | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2021 | K203649 | TruAbutment DS, TruBase | NHA Endosseous Dental Implant Abutment |
| 8 Jul 2021 | K202579 | TruAbutment DS, TruBase | NHA Endosseous Dental Implant Abutment |
| 4 Jun 2021 | K201842 | TruBase S | NHA Endosseous Dental Implant Abutment |
| 26 Mar 2021 | K201197 | TruAbutment DS, TruBase S | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2020 | K200817 | URIS OMNI Narrow System & Prosthetic | DZE Root-Form Endosseous Implant |
| 19 Jun 2020 | K191913 | TruAbutment DS | NHA Endosseous Dental Implant Abutment |
| 29 Jan 2020 | K183106 | TruAbutment DS | NHA Endosseous Dental Implant Abutment |
| 11 Sep 2018 | K171532 | TruBase S | NHA Endosseous Dental Implant Abutment |
| 4 May 2018 | K172100 | URIS OMNI System | DZE Root-Form Endosseous Implant |
| 23 Jan 2018 | K172304 | TruAbutment DS | NHA Endosseous Dental Implant Abutment |
| 25 May 2017 | K170259 | TruAbutment DS | NHA Endosseous Dental Implant Abutment |
| 20 May 2016 | K152559 | TruAbutment DS | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: TruAbutment Korea Co Ltd (17).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TRUABUTMENT INC.FDA reg. 3012422693 | Irvine, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053343). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.