BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ROBIN CORDLESS HANDPIECE

    K Number: K832063 · Decision Aug 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    7
    Review Days
    60

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    Basic Information

    Device Name
    ROBIN CORDLESS HANDPIECE
    K Number
    K832063
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Kaycor Intl., Ltd.
    Date Received
    June 27, 1983
    Decision Date
    August 26, 1983
    Product Code
    EKX
    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
    EKX Handpiece, Direct Drive, Ac-Powered

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