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510(k) Data Aggregation

    K Number
    K123731
    Device Name
    BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
    Date Cleared
    2013-01-04

    (30 days)

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

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
    Device Description
    Not Found
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    K Number
    K103745
    Device Name
    BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
    Date Cleared
    2011-07-20

    (209 days)

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

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.
    Device Description
    Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains moisturizers, humectants, a protein, and patented salivary enzymes that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.
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    K Number
    K101477
    Device Name
    BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
    Manufacturer
    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)
    Date Cleared
    2010-09-28

    (123 days)

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

    GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
    Device Description
    Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.
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