FDA 510(k)

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

Número K: K220179 · 2023-09-22

RequerenteFoshan Coxo Medical Instrument Co., Ltd.

Data da decisão2023-09-22

Código do produtoEFB

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K220179. 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 Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220179.

When did High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors receive FDA 510(k) clearance?

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors received FDA 510(k) clearance on 2023-09-22, under 510(k) number K220179.

Who is the listed applicant for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

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

What is the FDA product code for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors?

The FDA product code for High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors is EFB.

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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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