FDA 510(k)

Highspeed Airturbine Handpiece

Número K: K202371 · 2021-11-08

RequerenteBeijing Dongbo Dental Handpiece Co., Ltd.

Data da decisão2021-11-08

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Highspeed Airturbine Handpiece 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 2021-11-08 under 510(k) number K202371. 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 Highspeed Airturbine Handpiece?

Highspeed Airturbine Handpiece is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Beijing Dongbo Dental Handpiece Co., Ltd.. The 510(k) number is K202371.

When did Highspeed Airturbine Handpiece receive FDA 510(k) clearance?

Highspeed Airturbine Handpiece received FDA 510(k) clearance on 2021-11-08, under 510(k) number K202371.

Who is the listed applicant for Highspeed Airturbine Handpiece?

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 Highspeed Airturbine Handpiece?

The FDA product code for Highspeed Airturbine Handpiece is EFB.

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

K172543High-speed Turbine Handpieces for Single Use

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.

Fonte oficial

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