BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE

    K Number: K070001 · Decision Feb 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
    K Number
    K070001
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mti Precision Products
    Date Received
    January 3, 2007
    Decision Date
    February 2, 2007
    Product Code
    EFB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFB Handpiece, Air-Powered, Dental

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    Other Clearances by Mti Precision Products

    K Number Device Name
    K960541 LYNX DPA DISPOSABLE PROPHY ANGLE
    K940261 LYNX LOW-SPEED HANDPIECE
    K901488 LYNX-SM, SCLAER DENTAL HANDPIECE
    K895736 LYNX-HIGH SPEED HANDPIECE