Search Results
Found 1 results
510(k) Data Aggregation
K Number
K122663Device Name
ORAMOIST
Manufacturer
Date Cleared
2013-05-30
(272 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
QUANTUM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OraMoist" Patches for Dry Mouth promotes lubrication of the oral mucosa that may be dry due to side effects of medication, chemo or radiation therapy, or as a symptom of Sjogren's syndrome, or because of oral inflammation. OraMoist Patches for Dry Mouth provides temporary relief for dry mouth.
Device Description
OraMoist® Patches for Dry Mouth is formulated as an oral tablet that adheres to soft tissues of the mouth and dissolves slowly moisturizing the buccal cavity for hours. The tablets are packaged individually in low density polyethylene foil. Each tablet consists of a mixture of electrolytes, natural lubricants, flavoring agents, and enzymes, and an adherent polymer.
Ask a Question
Ask a specific question about this device
Page 1 of 1