510(k) K251388

Device
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.
510(k) number
K251388
Product code
EFB
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-12
Date received
2025-05-05
Regulation
872.4200
Classification name
Handpiece, Air-Powered, Dental
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Salon Chen
Address
Rm. 401, Floor 4, Block C, #7, Gui Dan Rd. Side Section Luo Cun St., Shi Shan Nanhai District Foshan CN 528226 528226

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EFB

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