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510(k) Data Aggregation

    K Number
    K071617
    Device Name
    ORAL NEUTRALIZER
    Manufacturer
    Date Cleared
    2007-10-19

    (128 days)

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

    ORAL BIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A refreshing gel, liquid, or spray that diminishes dry oral discomfort, neutralizes mouth odors, neutralizes and moisturizes oral biofilm, and other symptoms of a chronic or temporary dry mouth/xerostemia as a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress, or aging.
    Device Description
    Oral Neutralizer, like the mentioned pre existing devices, is an artificial saliva substitute which, like natural saliva, contains lubricating, neutralizing, and moistening properties to help alleviate the symptoms of dry mouth (xerostomia).
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