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510(k) Data Aggregation

    K Number
    K041755
    Device Name
    CROMAX HIGH SPEED TURBINE HANDPIECE
    Date Cleared
    2004-10-22

    (115 days)

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

    J.R. MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is an air-powered dental handpiece for use in general dentistry.
    Device Description
    The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks. The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed. Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.
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