Submission Details
| 510(k) Number | K252374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2025 |
| Decision Date | September 11, 2025 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |