BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

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

    K Number: K220179 · Decision Sep 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    7
    Review Days
    609

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    Basic Information

    Device Name
    High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
    K Number
    K220179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foshan Coxo Medical Instrument Co., Ltd.
    Date Received
    January 21, 2022
    Decision Date
    September 22, 2023
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFB Handpiece, Air-Powered, Dental

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