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510(k) Data Aggregation

    K Number
    K092214
    Device Name
    CHIROPRO L SYSTEM
    Manufacturer
    BIEN-AIR DENTAL, SA
    Date Cleared
    2009-12-15

    (146 days)

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

    BIEN-AIR DENTAL, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chiropro L system is intended for use in dental surgery, endodontics, and implantology. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
    Device Description
    The Chiropro L system consists of a software-based drive unit that controls the speed of a dental micromotor. The Chiropro L system offers three different functional modes with operating parameters specific to a particular application (Implantology, Endodontics, and Dental Surgery). The Chiropro L system is equipped with an integrated peristaltic pump for use with external irrigation tubing allowing irrigation of the working area. The device is operated via the command buttons on the tabletop console or through a foot control. For implantology purposes, the Chiropro L system is intended to be used with a contra-angle handpiece with a 20:1 gearing ratio and a rotational speed between 5 rpm to 2000 rpm (designed to operate burs according to ISO1797-1, type 2). Two versions of the handpiece are available, with and without optical fibers conducting the light emitted by the motor to the surgical field.
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