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510(k) Data Aggregation

    K Number
    K130455
    Device Name
    430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
    Manufacturer
    DENTALEZ GROUP, STARDENTAL DIVISION
    Date Cleared
    2013-09-25

    (215 days)

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

    DENTALEZ GROUP, STARDENTAL DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.
    Device Description
    The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used. The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM. The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.
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    K Number
    K083252
    Device Name
    NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
    Manufacturer
    DENTALEZ GROUP, STARDENTAL DIVISION
    Date Cleared
    2009-02-18

    (106 days)

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

    DENTALEZ GROUP, STARDENTAL DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.
    Device Description
    The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis. The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.
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