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510(k) Data Aggregation

    K Number
    K163029
    Device Name
    Hydris™ Oral Rinse
    Manufacturer
    BIOPHARM CONSULT, L.L.C.
    Date Cleared
    2017-06-19

    (231 days)

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

    BIOPHARM CONSULT, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms and discomfort of dry mouth, refresh, moisturize/hydrate, clean, soothe oral irritation and lubricate oral dryness.
    Device Description
    Hydris™Oral Rinse(Hydris) is a specially formulated water soluble artificial saliva substitute with a pH between 5.00 to 7.00 for use at home in the oral cavity. The proposed device 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/hydrating, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, semi-viscous blue colored liquid packaged in three sizes, including 8.5 FL OZ, 16.9 FL OZ and 33.8 FL OZ white polyethylene terephthalate (PET) bottles with white polypropylene caps. The shelf-life is 2 years.
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