FDA 510(k)

High-speed Turbine Handpieces for Single Use

Número K: K172543 · 2018-07-11

RequerenteBeijing Dongbo Dental Handpiece Co., Ltd.

Data da decisão2018-07-11

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

High-speed Turbine Handpieces for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K172543. 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 High-speed Turbine Handpieces for Single Use?

High-speed Turbine Handpieces for Single Use is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K172543.

When did High-speed Turbine Handpieces for Single Use receive FDA 510(k) clearance?

High-speed Turbine Handpieces for Single Use received FDA 510(k) clearance on 2018-07-11, under 510(k) number K172543.

Who is the listed applicant for High-speed Turbine Handpieces for Single Use?

The FDA 510(k) record lists Beijing Dongbo Dental Handpiece Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for High-speed Turbine Handpieces for Single Use?

The FDA product code for High-speed Turbine Handpieces for Single Use is EFB.

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Outros registros que listam Beijing Dongbo Dental Handpiece Co., Ltd. como candidato(a)

K202371Highspeed Airturbine 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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