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

    CONFORM

    K Number: K062157 · Decision Oct 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    913
    Applicant Total
    13
    Review Days
    77

    Basic Information

    Device Name
    CONFORM
    K Number
    K062157
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    APEX DENTAL MATERIALS, INC.
    Date Received
    July 28, 2006
    Decision Date
    October 13, 2006
    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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