FDA 510(k)

High speed air turbine handpiece

N.º K: K251389 · 2026-01-12

SolicitanteFoshan Topmed Dental Co., Ltd.

Fecha de decisión2026-01-12

Código de productoEFB

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Foshan Topmed Dental Co., Ltd. como solicitante

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 pulido dental a aire (Perio-Mate); Sistema de pulido dental a aire (Perio Mate Nozzle Tip)Nakanishi, Inc.

Fuente oficial

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