K231297 is an FDA 510(k) clearance for the Firstar Dental Unit. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Firstar Dental Company (Kent, US). The FDA issued a Cleared decision on January 27, 2025, 634 days after receiving the submission on May 4, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K231297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2023 |
| Decision Date | January 27, 2025 |
| Days to Decision | 634 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |