Cleared Traditional

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)

K251388 · Foshan Topmed Dental Co., Ltd. · Dental
Jan 2026
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

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), 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 review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K251388 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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