510(k) K251388 ยท EFB Handpiece, Air-Powered, Dental
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)
| Applicant | Foshan Topmed Dental Co., Ltd., Foshan, CN |
| Decision | Substantially Equivalent, Jan 12, 2026 |
| Received | May 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251388
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.