Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122663
    Device Name
    ORAMOIST
    Manufacturer
    Date Cleared
    2013-05-30

    (272 days)

    Product Code
    Regulation Number
    N/A
    Why 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