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

    ZENTIH FLOWABLE COMPOSITE (MULTIPLE)

    K Number: K970683 · Decision Jul 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    14
    Review Days
    141

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    Basic Information

    Device Name
    ZENTIH FLOWABLE COMPOSITE (MULTIPLE)
    K Number
    K970683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Foremost Dental Mfg., Inc.
    Date Received
    February 24, 1997
    Decision Date
    July 15, 1997
    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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