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

    Oral-B 5% Sodium Fluoride Varnish

    K Number: K153334 · Decision May 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    16
    Review Days
    183

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    Basic Information

    Device Name
    Oral-B 5% Sodium Fluoride Varnish
    K Number
    K153334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3260
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    November 19, 2015
    Decision Date
    May 20, 2016
    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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