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510(k) Data Aggregation

    K Number
    K193336
    Device Name
    Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
    Manufacturer
    Synedgen, Inc.
    Date Cleared
    2020-05-27

    (177 days)

    Product Code
    OLR, MGO, MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synedgen, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
    Device Description
    Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.
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