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510(k) Data Aggregation

    K Number
    K020009
    Device Name
    BRACE EZE
    Manufacturer
    UDENT, INC.
    Date Cleared
    2002-02-11

    (40 days)

    Product Code
    EGD
    Regulation Number
    872.6890
    Why did this record match?
    Applicant Name (Manufacturer) :

    UDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.
    Device Description
    Brace Eze is an orally applied gel that is applied to the brackets of orthodontic braces.
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