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510(k) Data Aggregation

    K Number
    K031809
    Device Name
    PERIO PROTECT TRAY
    Manufacturer
    Date Cleared
    2004-01-23

    (225 days)

    Product Code
    Regulation Number
    872.6870
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERIO PROTECT LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Perio Protect Tray is intended to be used to place solutions of the clinician's choice into gingival crevices or periodontal pockets. The design of the Perio Protect Tray permits placement of solutions deeper into the crevice/pocket than is possible with traditional fluoride trays. The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
    Device Description
    The Perio Protect Tray is a custom fit tray made from impressions of the patents mouth taken by a licensed dentist. The patient impressions are then sent to a specialized dental laboratory which makes a custom fit tray for the individual patient.
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