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510(k) Data Aggregation

    K Number
    K181194
    Device Name
    SmartMouth DryMouth Oral Rinse
    Manufacturer
    Triumph Pharmaceuticals, Inc.
    Date Cleared
    2019-02-15

    (287 days)

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

    Triumph Pharmaceuticals, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.
    Device Description
    SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.
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