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510(k) Data Aggregation

    K Number
    K181134
    Device Name
    G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
    Manufacturer
    Sunstar Americas Inc
    Date Cleared
    2018-07-13

    (74 days)

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

    Sunstar Americas Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    G+U•M® HYDRAL™ Dry Mouth Oral Gel helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G•U•M® HYDRAL™ Dry Mouth Oral Rinse helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness. G.U.M® HYDRAL™ Dry Mouth Oral Spray helps soothe oral tissue and relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
    Device Description
    G+U•M® HYDRAL™ Dry Mouth Oral Gel, G•U•M® HYDRAL™ Dry Mouth Oral Rinse and G•U•M® HYDRAL™ Dry Mouth Oral Spray are specifically formulated artificial saliva with a pH between 5.00 to 7.00. The proposed device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, soothing, and humectant, sweeteners and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth. The device is provided in a realy to use at home. G-U-M- HYDRAL" " Dry Mouth Oral Gel is supplied in a 1.5-oune Polyethylene Laminate tube. G-U-M " Hrise is spay i.69 fluid ounce bottle. Both rinse and spray are packaged in Polyethylene Terephthalate (PET) bottles with white polypropylene caps.
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