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    K Number
    K040153
    Device Name
    I-TEC PORTABLE DENTAL OPERATORY
    Manufacturer
    INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER
    Date Cleared
    2004-05-21

    (119 days)

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

    INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC micromotor that can be turned on or off by a foot switch. It is intended for elective dental applications such as cutting a tooth for crown preparation and use in general dental application, inlay or filling finishing, polishing and endodontic treatment, with use of a contra-angle Doriot Style attachment of equal speed. The speed is adjustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm.
    Device Description
    The PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC micromotor that can be turned on or off by a foot switch. The speed is adjustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm.
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