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510(k) Data Aggregation
K Number
K123731Device 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/AWhy 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
K103745Device 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/AWhy 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
K101477Device 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/AWhy 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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