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

    Highspeed Airturbine Handpiece

    K Number: K202371 · Decision Nov 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    446

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    Basic Information

    Device Name
    Highspeed Airturbine Handpiece
    K Number
    K202371
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Dongbo Dental Handpiece Co., Ltd.
    Date Received
    August 19, 2020
    Decision Date
    November 8, 2021
    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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    Other Clearances by Beijing Dongbo Dental Handpiece Co., Ltd.

    K Number Device Name
    K172543 High-speed Turbine Handpieces for Single Use