FDA 510(k)

Dental High-speed Handpiece and Accessories

N.º K: K173943 · 2018-07-24

SolicitanteMicrop Technology (Taiwan), Inc.

Fecha de decisión2018-07-24

Código de productoEFB

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dental High-speed Handpiece and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Microp Technology (Taiwan), Inc.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K173943. 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 Dental High-speed Handpiece and Accessories?

Dental High-speed Handpiece and Accessories is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Microp Technology (Taiwan), Inc.. The 510(k) number is K173943.

When did Dental High-speed Handpiece and Accessories receive FDA 510(k) clearance?

Dental High-speed Handpiece and Accessories received FDA 510(k) clearance on 2018-07-24, under 510(k) number K173943.

Who is the listed applicant for Dental High-speed Handpiece and Accessories?

The FDA 510(k) record lists Microp Technology (Taiwan), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental High-speed Handpiece and Accessories?

The FDA product code for Dental High-speed Handpiece and Accessories is EFB.

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Otros registros que enlistan a Microp Technology (Taiwan), Inc. como solicitante

K202786Piezas de mano de bajo rendimiento y accesorios dentales

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.K251389High speed air turbine handpieceFoshan 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.

Fuente oficial

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