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510(k) Data Aggregation

    K Number
    K072306
    Device Name
    BIOXTRA MOISTURIZING GEL
    Manufacturer
    BIO-X HEALTHCARE S.A.
    Date Cleared
    2007-11-15

    (90 days)

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

    BIO-X HEALTHCARE S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: Under the supervision of a healthcare professional, BioXtra® Moisturizing Gel is indicated for relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste and replaces missing saliva feel. OTC: BioXtra® Moisturizing Gel is indicated for the symptomatic relief from the effects of chronic or temporary xerostomia (dry mouth), mouth discomfort, mouth odors and other oral symptoms associated with dry mouth.
    Device Description
    BioXtra® Moisturizing Gel contains a patented formulation of milk proteins and salivary enzymes which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. The product is supplied in a 1.4 fl. oz aluminum tube.
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