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

    ABRASIVE WHEELS

    K Number: K781777 · Decision Dec 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    0
    Applicant Total
    279
    Review Days
    68

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    Basic Information

    Device Name
    ABRASIVE WHEELS
    K Number
    K781777
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6010
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dentsply Intl.
    Date Received
    October 13, 1978
    Decision Date
    December 20, 1978
    Product Code
    EJQ
    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
    EJQ Wheel, Polishing Agent

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