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510(k) Data Aggregation

    K Number
    K073061
    Device Name
    THE PROXIVENT KIT
    Manufacturer
    COLL PARTNERS LTD.
    Date Cleared
    2008-02-29

    (122 days)

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

    COLL PARTNERS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.
    Device Description
    The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface area of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed. The Proxivent Kit comprises two components, Proxivent Varnish and Proxivent Matrix Pads. The varnish component is intended for application on easily accessible sites such as the buccal and lingual surfaces. The matrix pads include three shapes; round discs; an anatomically H-shaped conformation and an elongated H-shaped conformation (HL). The pads are made of varnishes containing cross-linked gelatin that obdurate dental tubules and release fluoride to strategically targeted tooth surfaces for optimal effects at the microscopic and molecular level at sites not easily accessed. Proxivent matrix pads are small, comfortable devices that denta." professionals can position, for example, between the teeth or at a furcation where there is, or could be, sensitivity. Proxivent matrix pads are engineered to expand gently and lock into place, soften and protect exposed dentin and exude non-toxic micro-doses of fluoride onto and into the tooth crystals (e.g., of the cemetum and dentir ) at inaccessible regions, for example, furcations and between the teeth. The matrix pads biodegrade following their fluoride release.
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