TruAbutment Inc.
FDA Regulatory Profile
TruAbutment Inc. has 1 FDA recall, 1 inspection, 17 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-1313-2025 · Class II · Dec 27, 2023
- Latest inspection
- Jan 21, 2025 · OAI
- Latest 510(k)
- Jul 3, 2025
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 17 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1313-2025 | Class II | Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8… | Dec 27, 2023 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3012422693 | Irvine, CA | 1 | Jan 21, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K201197 | TruAbutment DS, TruBase S | Mar 26, 2021 |
| K200817 | URIS OMNI Narrow System & Prosthetic | Oct 7, 2020 |
| K191913 | TruAbutment DS | Jun 19, 2020 |
| K183106 | TruAbutment DS | Jan 29, 2020 |
| K171532 | TruBase S | Sep 11, 2018 |
| K172100 | URIS OMNI System | May 4, 2018 |
| K172304 | TruAbutment DS | Jan 23, 2018 |
| K170259 | TruAbutment DS | May 25, 2017 |
| K152559 | TruAbutment DS | May 20, 2016 |