FDA 510(k)

High speed air turbine handpiece

Número K: K251389 · 2026-01-12

RequerenteFoshan Topmed Dental Co., Ltd.

Data da decisão2026-01-12

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

High speed air turbine handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Topmed Dental Co., Ltd.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251389. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the High speed air turbine handpiece?

High speed air turbine handpiece is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Foshan Topmed Dental Co., Ltd.. The 510(k) number is K251389.

When did High speed air turbine handpiece receive FDA 510(k) clearance?

High speed air turbine handpiece received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251389.

Who is the listed applicant for High speed air turbine handpiece?

The FDA 510(k) record lists Foshan Topmed Dental Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High speed air turbine handpiece?

The FDA product code for High speed air turbine handpiece is EFB.

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Outros registros que listam Foshan Topmed Dental Co., Ltd. como candidato(a)

K251388Dental 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)

Dispositivos Relacionados (Código: EFB)

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251388Dental 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)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.K241880Sistema de Polimento de Dentes com Ar (Perio-Mate); Sistema de Polimento de Dentes com Ar (Ponta de Jato do Perio Mate)Nakanishi, Inc.

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