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Sign in to claim this brandTruAbutment Inc.
United States·US-MF-000043448
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 17666, Fitch, Irvine, United States
- Website
- truabutment.com
- —
- —
- [email protected]
- Phone
- +1 714 956 1488
- PRRC Contact
- Donguk Shin
- EUDAMED SRN
- US-MF-000043448
- FDA FEI Number
- 3012422693
- DUNS Number
- 079875622
Catalogue (243)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TruAbutment DS | CA60-CS | FDA UDI | Class II | Active |
| TruAbutment DS | CN33-CB | FDA UDI | Class II | Active |
| TruAbutment DS | STR-CS | FDA UDI | Class II | Active |
| TruAbutment DS | BHN-CB | FDA UDI | Class II | Active |
| TruAbutment DS | AE30-CB | FDA UDI | Class II | Active |
| TruAbutment DS | NA3-CS | FDA UDI | Class II | Active |
| TruAbutment DS | AS3-CS | FDA UDI | Class II | Active |
| TruAbutment DS | KPS-CB | FDA UDI | Class II | Active |
| TruAbutment DS | NR6-CS | FDA UDI | Class II | Active |
| TruAbutment DS | STW-CS | FDA UDI | Class II | Active |
| TruAbutment DS | NDG-CB | FDA UDI | Class II | Active |
| TruAbutment DS | CA60-CB | FDA UDI | Class II | Active |
| TruAbutment DS | SXW-CS | FDA UDI | Class II | Active |
| TruAbutment DS | ZV4-CS | FDA UDI | Class II | Active |
| TruAbutment DS | AS4-CB | FDA UDI | Class II | Active |
| TruAbutment DS | DUN-CS | FDA UDI | Class II | Active |
| TruAbutment DS | CA38-CS | FDA UDI | Class II | Active |
| TruAbutment DS | NAW-CS | FDA UDI | Class II | Active |
| TruAbutment DS | NAR-CB | FDA UDI | Class II | Active |
| TruAbutment DS | AS5-CS | FDA UDI | Class II | Active |
| TruAbutment DS | AE54-CB | FDA UDI | Class II | Active |
| TruAbutment DS | AE48-CB | FDA UDI | Class II | Active |
| TruAbutment DS | NSN-CB | FDA UDI | Class II | Active |
| TruAbutment DS | DSU-CB | FDA UDI | Class II | Active |
| TruAbutment DS | MCS-CS | FDA UDI | Class II | Active |
| TruAbutment DS | CN50-CB | FDA UDI | Class II | Active |
| TruAbutment DS | ZV5-CB | FDA UDI | Class II | Active |
| TruAbutment DS | STW-CB | FDA UDI | Class II | Active |
| TruAbutment DS | CA50-CS | FDA UDI | Class II | Active |
| TruAbutment DS | BH35-CS | FDA UDI | Class II | Active |
| TruAbutment DS | MCN-CB | FDA UDI | Class II | Active |
| TruAbutment DS | SBN-CS | FDA UDI | Class II | Active |
| TruAbutment DS | KPR-CB | FDA UDI | Class II | Active |
| TruAbutment DS | BH57-CS | FDA UDI | Class II | Active |
| TruAbutment DS | OTM-CS | FDA UDI | Class II | Active |
| TruAbutment DS | SXR-CB | FDA UDI | Class II | Active |
| TruAbutment DS | CN43-CS | FDA UDI | Class II | Active |
| TruAbutment DS | NR6-CB | FDA UDI | Class II | Active |
| TruAbutment DS | AE42-CB | FDA UDI | Class II | Active |
| TruAbutment DS | BC41-CS | FDA UDI | Class II | Active |
| TruAbutment DS | BC60-CB | FDA UDI | Class II | Active |
| TruAbutment DS | ZV3-CS | FDA UDI | Class II | Active |
| TruAbutment DS | AS4-CS | FDA UDI | Class II | Active |
| TruAbutment DS | AE48-CS | FDA UDI | Class II | Active |
| TruAbutment DS | ZVN-CS | FDA UDI | Class II | Active |
| TruAbutment DS | SXW-CB | FDA UDI | Class II | Active |
| TruAbutment DS | MCN-CS | FDA UDI | Class II | Active |
| TruAbutment DS | MRD-CB | FDA UDI | Class II | Active |
| TruAbutment DS | BC41-CB | FDA UDI | Class II | Active |
| TruAbutment DS | AE36-CS | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 27, 2023 | Z-1313-2025 | — | open, classified | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately |