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510(k) Data Aggregation

    K Number
    K140350
    Device Name
    VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
    Manufacturer
    PREVENTIVE TECHNOLOGIES, INC.
    Date Cleared
    2014-12-12

    (304 days)

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

    PREVENTIVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.
    Device Description
    Not Found
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    K Number
    K100539
    Device Name
    PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
    Manufacturer
    PREVENTIVE TECHNOLOGIES, INC.
    Date Cleared
    2010-06-17

    (112 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    PREVENTIVE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
    Device Description
    PREVENTECH Prophylaxis Paste with Fluoride is an oral cavity abrasive polishing agent containing sodium fluoride in a blend of enamel polishing and cleaning abrasive agents in a paste form designed for professional application to the teeth during the course of standard dental hygiene procedures. PREVENTECH Prophylaxis Paste with Fluoride is sweetened with Xylitol and offered in various grit levels and various flavors. The standard mode of application for PREVENTECH Prophylaxis Paste with Fluoride is by use of a low speed Dental Handpiece and accessories, (21 § CFR 872.4200) and a Prophylaxis Cup, (21§ CFR 872.6290).
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