FDA 510(k)

Ferramentas e Acessórios de Ferramentas de Baixa Velocidade para Odontologia

Número K: K202786 · 2021-09-03

RequerenteMicrop Technology (Taiwan), Inc.

Data da decisão2021-09-03

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Low-speed Handpieces 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 2021-09-03 under 510(k) number K202786. 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 Dental Low-speed Handpieces and Accessories?

Dental Low-speed Handpieces and Accessories is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Microp Technology (Taiwan), Inc.. The 510(k) number is K202786.

When did Dental Low-speed Handpieces and Accessories receive FDA 510(k) clearance?

Dental Low-speed Handpieces and Accessories received FDA 510(k) clearance on 2021-09-03, under 510(k) number K202786.

Who is the listed applicant for Dental Low-speed Handpieces 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 Low-speed Handpieces and Accessories?

The FDA product code for Dental Low-speed Handpieces and Accessories is EFB.

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Outros registros que listam Microp Technology (Taiwan), Inc. como candidato(a)

K173943Dental High-speed Handpiece and Accessories

Dispositivos Relacionados (Código: EFB)

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 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.

Fonte oficial

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