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    K Number
    K140685
    Device Name
    ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
    Manufacturer
    SYBRONENDO
    Date Cleared
    2014-07-02

    (106 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRONENDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoVac® system is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
    Device Description
    The EndoVac® System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. EndoVac® Apical Negative Pressure Irrigation System is used in root canal therapy and is comprised of four main components. The Multi-Port Adapter is used to connect the Master Delivery Tip to the dental office Hi-Vac system. The Master Delivery Tip provides a constant flow of irrigant that lowers the risk of overflow due to continuous suction. Additional tips include the MacroCannula which is used to remove coarse debris after instrumentation, and the MicroCannula which features microscopic evacuation holes allowing the irrigant to flow to the apical termination.
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