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    K Number
    K072082
    Device Name
    GUMEASE DENTAL MOUTHPIECE
    Manufacturer
    BIOMEDEVICE LTD.
    Date Cleared
    2007-11-05

    (98 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMEDEVICE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gumEase® dental mouthpiece provides temporary relief from oral discomfort resulting from dental work, brace pain, denture irritation, post surgical pain or minor oral trauma.
    Device Description
    The gumEase® dental mouth piece is manufactured from biocompatible plastic tubing that is filled with a NaCl solution.
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