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FDA 510(k)

High-speed air turbine handpiece / Low-speed air turbine handpiece

N.º K: K181691 · 2020-05-26

SolicitanteFoshan Wenjian Medical Instrument Co., Ltd.
Fecha de decisión2020-05-26
Código de productoEFB
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

High-speed air turbine handpiece / Low-speed air turbine handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Wenjian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K181691. 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 / Low-speed air turbine handpiece?

High-speed air turbine handpiece / Low-speed air turbine handpiece is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Foshan Wenjian Medical Instrument Co., Ltd.. The 510(k) number is K181691.

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

High-speed air turbine handpiece / Low-speed air turbine handpiece received FDA 510(k) clearance on 2020-05-26, under 510(k) number K181691.

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

The FDA 510(k) record lists Foshan Wenjian Medical Instrument 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 / Low-speed air turbine handpiece?

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

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Dispositivos relacionados (Código: EFB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.K251389High speed air turbine handpieceFoshan Topmed Dental 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 GmbHK240337Dental 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.

Fuente oficial

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