BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer

    K Number: K182833 · Decision Feb 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    6
    Review Days
    122

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    Basic Information

    Device Name
    ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
    K Number
    K182833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Argen Corporation
    Date Received
    October 9, 2018
    Decision Date
    February 8, 2019
    Product Code
    EIH
    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
    EIH Powder, Porcelain

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