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510(k) Data Aggregation
K Number
K041563Device Name
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
Manufacturer
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
Date Cleared
2004-08-27
(78 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.
OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
Device Description
OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.
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