K251388 is an FDA 510(k) clearance for the Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41). This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Foshan Topmed Dental Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on January 12, 2026, 252 days after receiving the submission on May 5, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K251388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2025 |
| Decision Date | January 12, 2026 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFB - Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |