FDA 510(k)

Dental Low-speed Turbine Handpiece

Número K: K170236 · 2017-11-21

RequerenteGuangdong Jinme Medical Technology Co., Ltd.

Data da decisão2017-11-21

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Low-speed Turbine Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K170236. 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 Turbine Handpiece?

Dental Low-speed Turbine Handpiece is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Guangdong Jinme Medical Technology Co., Ltd.. The 510(k) number is K170236.

When did Dental Low-speed Turbine Handpiece receive FDA 510(k) clearance?

Dental Low-speed Turbine Handpiece received FDA 510(k) clearance on 2017-11-21, under 510(k) number K170236.

Who is the listed applicant for Dental Low-speed Turbine Handpiece?

The FDA 510(k) record lists Guangdong Jinme Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Low-speed Turbine Handpiece?

The FDA product code for Dental Low-speed Turbine Handpiece is EFB.

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Outros registros que listam Guangdong Jinme Medical Technology Co., Ltd. como candidato(a)

K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)K240340Surgical Drive System (Model: ES70, ES90, E8)K170229Dental High-speed Turbine Handpiece

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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