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

    CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)

    K Number: K973919 · Decision Dec 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    7
    Review Days
    62

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    Basic Information

    Device Name
    CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
    K Number
    K973919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medental Intl.
    Date Received
    October 15, 1997
    Decision Date
    December 16, 1997
    Product Code
    LBH
    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
    LBH Varnish, Cavity

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