Truabutment, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Truabutment, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 275 days. Since 2017 the median was 286 days, against 191 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 254 |
| 2017 | 1 | 118 |
| 2018 | 3 | 297 |
| 2019 | 0 | — |
| 2020 | 3 | 338 |
| 2021 | 4 | 314 |
| 2022 | 1 | 206 |
| 2023 | 2 | 218 |
| 2024 | 1 | 138 |
| 2025 | 1 | 261 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Truabutment, Inc. took a median 286 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 13 | 13 |
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
Review panels
- Dental (17)
Most recent Truabutment, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243255 | URIS Long Implant & Abutments | DZE | 2025-07-03 | 261 |
| K241485 | TruAbutment DS; TruBase | NHA | 2024-10-09 | 138 |
| K230438 | URIS Smart Path Implant System & Prosthetic | DZE | 2023-12-29 | 311 |
| K231874 | AOT & T-L Abutment | NHA | 2023-10-30 | 126 |
| K213961 | TruAbutment DS, TruBase | NHA | 2022-07-14 | 206 |
| K203649 | TruAbutment DS, TruBase | NHA | 2021-09-15 | 275 |
| K202579 | TruAbutment DS, TruBase | NHA | 2021-07-08 | 303 |
| K201842 | TruBase S | NHA | 2021-06-04 | 333 |
| K201197 | TruAbutment DS, TruBase S | NHA | 2021-03-26 | 326 |
| K200817 | URIS OMNI Narrow System & Prosthetic | DZE | 2020-10-07 | 191 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2023-12-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Truabutment, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Truabutment, Inc.” (first 2016, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Truabutment, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Truabutment, Inc. is 275 days. Since 2017: 286 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Truabutment, Inc.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 13); DZE (Implant, Endosseous, Root-Form, 4).
Next steps
- See all 17 Truabutment, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Truabutment, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.