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

    PANAVIA TC, AND PANAVIA OPAQUE

    K Number: K862232 · Decision Jul 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    913
    Applicant Total
    25
    Review Days
    48

    Basic Information

    Device Name
    PANAVIA TC, AND PANAVIA OPAQUE
    K Number
    K862232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    KURARAY CO.
    Date Received
    June 11, 1986
    Decision Date
    July 29, 1986
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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