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510(k) Data Aggregation

    K Number
    K211721
    Device Name
    PS System
    Manufacturer
    Inter-Med, INC.
    Date Cleared
    2021-12-02

    (181 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    NYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
    Device Description
    The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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    K Number
    K162436
    Device Name
    EndoVac Pure
    Manufacturer
    Kerr Corporation
    Date Cleared
    2016-12-21

    (112 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    NYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoVac™ Pure System is intended for the delivery and evacuation of endodontic irrigation solutions and removing debris of injured or necrotic pulp tissue during root canal procedures.
    Device Description
    The EndoVac Pure™ system builds on the EndoVac System and presents a unique way to irrigate during root canal treatments. The system is an apical negative pressure system that draws fluid apically by way of evacuation, reducing the risk of apical irrigant extrusion during root canal procedures. The vacuum is routed through the system and controlled independently through the dental chair vacuum system. The fluid delivery is controlled by peristaltic pumps. The pumps are driven by Printed Circuit Board Assemblies (PCBA) and controlled by Field Programmable Gate Array (FPGA) configuration files.
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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?
    Product Code :

    NYL

    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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    K Number
    K100606
    Device Name
    VATEA ENDONTIC IRRIGATION SYSTEM
    Manufacturer
    REDENT NOVA LTD
    Date Cleared
    2010-05-28

    (86 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    NYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
    Device Description
    The VATEA device is a self contained, digitally-controlled fluid delivery unit consisting of a pump unit console, irrigation reservoir and tubing intended to be connected to an endodontic file. The device consists of a positive pressure peristaltic pump console with control panel, LCD display, irrigation reservoir, disposable silicone tubing, and a footswitch control to provide irrigation during endodontic rocedures. One end of the silicone tubing connects to the VATEA and the other end connects to the dental handpiece using a silicone ring. The silicone ring is elastic, and may be stretched to the domar handpiece as my of dental handpieces used in endodontic procedures. The irrigation reservoir is filled as needed with sodium hypochlorite solution for irrigation during endodontic rocedures. The irrigation fluid is pumped from the reservoir and then out of the silicone tubing, proodation: the internet of the tooth. The silicone tubing for the delivery of the iring the lumand the silicone ring connecting the pump to the dental handpiece are disposable and replaced after each treatment. The irrigation fluid flow may be switched on and off with a footswitch that is connected to the VATEA. The fingulon had now his his of the device are displayed on the LCD screen on the control r no how rate and operation is 0, and the user must increase the flow rate using the - / + buttons on panel. The using for face of the irrigation fluid. The irrigation fluid flow rate may be adjusted the control parter in increments of 1 ml/min using the - /+ push-button control on the control panel. The VATEA is an electronically operated device, powered by a rechargeable battery.
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    K Number
    K052271
    Device Name
    RINSENDO
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2006-05-26

    (280 days)

    Product Code
    NYL
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    NYL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RinsEndo is used for root canal irrigation/ disinfection.
    Device Description
    Not Found
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