ClearanceBrief
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)

ApplicantFoshan Topmed Dental Co., Ltd., Foshan, CN
DecisionSubstantially Equivalent, Jan 12, 2026
ReceivedMay 5, 2025
TypeTraditional
FDA recordOpen 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.