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510(k) Data Aggregation

    K Number
    K033449
    Device Name
    PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
    Date Cleared
    2004-01-07

    (70 days)

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

    PROFESSIONAL DENTAL TECHNOLOGIES THERAPEUTICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
    Device Description
    The Double-Pro™ Prophylaxis Paste with Fluoride family of devices, manufactured by Professional Dental Technologies Therapeutics, Inc., are oral cavity abrasive polishing agents that contain fluoride, an abrasive (in one of several available levels of grit courseness), a swectener, water, flavoring, color, thickeners, and preservatives. Double-Pro™ is intended for use by dental professionals, during professionally administered dental prophylaxis treatment (tooth-cleaning), to polish and clean calculus, stains, and other accretions from the teeth. Double Pro™ prophy paste is applied to patients' teeth with a prophy angle and rotating rubber cup. Use of Double-ProTM Prophylaxis Paste with Fluoride family of devices is to be limited to individuals who are professional trained to perform dental prophylaxis.
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