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    K Number
    K131396
    Device Name
    WIRED MOUTH PROTECTOR (WMP)
    Manufacturer
    ELBA LABORATORIES, INC.
    Date Cleared
    2013-09-30

    (138 days)

    Product Code
    PFL
    Regulation Number
    872.6890
    Why did this record match?
    Product Code :

    PFL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.
    Device Description
    The Wired Mouth Protector consists of a non-sterile strip of non-latex foam with a slit in the middle that is inserted into the front of the mouth between the teeth and lip area with the slit in the center to provide a soft barrier to help protect the oral mucosa from contact with wired mouth hardware. It is changed three times daily or more often if needed.
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