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510(k) Data Aggregation

    K Number
    K173237
    Device Name
    Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
    Manufacturer
    Syendgen, Inc.
    Date Cleared
    2018-03-19

    (165 days)

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

    Syendgen, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.
    Device Description
    Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate. The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use. Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.
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