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    K Number
    K153334
    Device Name
    Oral-B 5% Sodium Fluoride Varnish
    Manufacturer
    YOUNG DENTAL MANUFACTURING CO 1, LLC.
    Date Cleared
    2016-05-20

    (183 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    YOUNG DENTAL MANUFACTURING CO 1, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
    Device Description
    Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post-operative sensitivity. 1mL of varnish contains 50 mg of sodium fluoride, equivalent to 22.6 mg fluoride ion. Varnish is sweetened with sucralose and Xylitol, and flavored. Varnish and applicator are packaged together in a molded opaque acclar tray, and sealed with a metallized foil.
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