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

    PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE

    K Number: K870797 · Decision May 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    88
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE
    K Number
    K870797
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Safco Dental Supply
    Date Received
    February 27, 1987
    Decision Date
    May 1, 1987
    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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