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510(k) Data Aggregation

    K Number
    K113146
    Device Name
    PCXX VARNISH
    Date Cleared
    2012-01-23

    (91 days)

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

    ROSS HEALTHCARE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - Treatment of hypersensitive teeth - Use on exposed dentin and root sensitivity - Under temporary restoratives and cements where post-operative sensitivity is of concern.
    Device Description
    PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces. The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces. PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used in predicate devices which include but are not limited to Duraflor, Duraphat and Fluorilaq. The product comes in a single unit dose package containing the varnish and separate applicator brush.
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