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

    CAVITY VARNISH

    K Number: K010255 · Decision Apr 20, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    7
    Review Days
    81

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    Basic Information

    Device Name
    CAVITY VARNISH
    K Number
    K010255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rite-Dent Manufacturing Corp.
    Date Received
    January 29, 2001
    Decision Date
    April 20, 2001
    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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