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510(k) Data Aggregation

    K Number
    K971622
    Device Name
    MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
    Date Cleared
    1997-06-20

    (49 days)

    Product Code
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to be used in endodontic therapy as an improved method for applying Zinc Oxide-Eugenol sealing cement directly to the inside surface of a prepared root canal to coat and seal the canal walls prior to the introduction of gutta percha (or other restorative and filling materials).
    Device Description
    The MPL Technologies Inc. Max-i-Probe Endodontic Sealer Delivery System is intended to be used in endodonic therapy by dental care professional in a clinical setting to apply Zinc Oxide-Eugenol sealing cement to the inside sufface of a prepared root canal prior to the introduction of gutta percha (or other restorative and filling materials). The Max-i-Probe Endodontic Sealer Delivery System consists of Zinc Oxide/Eugenol dental cement packaged in a delivery cartridge consisting of a type 304 stainless steel tube insert molded into a nylon cartridge. A sealer cartridge is loaded into a carridge-type syringe. The tube is inserted into the prepared canal. The cernent is expressed directly into the canal by squeezing the pressure activation handle while slowly withdrawing the probe from the canal. The cement is allowed to set. The empty cartridge is removed and discarded.
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