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510(k) Data Aggregation

    K Number
    K101172
    Device Name
    RDT3 HANDPIECE HEAD MODEL RDT3
    Manufacturer
    REDENT NOVA LTD
    Date Cleared
    2010-07-27

    (92 days)

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

    REDENT NOVA LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
    Device Description
    RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.
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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?
    Applicant Name (Manufacturer) :

    REDENT NOVA LTD

    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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