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)— 510(k) K251388

Name: FDA 510(k) clearance K251388
Creator: U.S. Food and Drug Administration
Published: 2026-01-12

Substantially Equivalent

Foshan Topmed Dental Co., Ltd.

FDA 510(k) clearance K251388 for 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), Substantially Equivalent on 2026-01-12. Applicant: Foshan Topmed Dental Co., Ltd.. Device class: 1.

Clearance details

Applicant: Foshan Topmed Dental Co., Ltd.
Product code: Product code EFB
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2025-05-05
Decision date: 2026-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foshan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFB

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K260029 — Firstar Dental Handpieces2026-10-01
K262144 — DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece2026-09-23
K251389 — High speed air turbine handpiece2026-01-12
K242179 — Synea Fusion Handpieces (Intensiv & Profin)2025-02-28
K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)2024-11-13

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.