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510(k) Data Aggregation

    K Number
    K070001
    Device Name
    MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
    Date Cleared
    2007-02-02

    (30 days)

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

    MTI PRECISION PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. - . Grinding and trimming on dentures and bridge work. - Polishing and finishing of natural dentition . - Endodontio abcess procedures . - Cavity preparation. t - Crown and cap preparation . - Post and pin setting . - Implant setting .
    Device Description
    The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.
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    K Number
    K960541
    Device Name
    LYNX DPA DISPOSABLE PROPHY ANGLE
    Date Cleared
    1996-03-28

    (50 days)

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

    MTI PRECISION PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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