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510(k) Data Aggregation

    K Number
    K142549
    Device Name
    Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
    Manufacturer
    J.C.E.C. Company, Inc. (doing business as Fountain Health Ca
    Date Cleared
    2015-05-26

    (258 days)

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

    J.C.E.C. Company, Inc. (doing business as Fountain Health Ca

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: Symptomatic treatment of xerostomia. Indications for Use: Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
    Device Description
    Oral77M products are specially formulated saliva substitutes which contain moisturizers, humectants, proteins and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.
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