Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list TruAbutment with 17 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 3, 2025: URIS Long Implant & Abutments.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 3, 2025 | URIS Long Implant & AbutmentsK243255 · DZE | 510(k) clearances |
| Oct 9, 2024 | TruAbutment DS; TruBaseK241485 · NHA | 510(k) clearances |
| Dec 29, 2023 | URIS Smart Path Implant System & ProstheticK230438 · DZE | 510(k) clearances |
| Dec 27, 2023 | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software VersClass II · Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately | Device recalls |
| Oct 30, 2023 | AOT & T-L AbutmentK231874 · NHA | 510(k) clearances |
| Jul 14, 2022 | TruAbutment DS, TruBaseK213961 · NHA | 510(k) clearances |
| Sep 15, 2021 | TruAbutment DS, TruBaseK203649 · NHA | 510(k) clearances |
| Jul 8, 2021 | TruAbutment DS, TruBaseK202579 · NHA | 510(k) clearances |
| Jun 4, 2021 | TruBase SK201842 · NHA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
