K251388
- 510(k) number
- K251388
- Device name
- 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. CN
- Product code
- EFB — Handpiece, Air-Powered, Dental
- Decision date
- 2026-01-12
- Date received
- 2025-05-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251388.pdf
Official FDA record: K251388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.