BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LYNX-SM, SCLAER DENTAL HANDPIECE

    K Number: K901488 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    47

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    Basic Information

    Device Name
    LYNX-SM, SCLAER DENTAL HANDPIECE
    K Number
    K901488
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Mti Precision Products
    Date Received
    March 29, 1990
    Decision Date
    May 15, 1990
    Product Code
    ELC
    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
    ELC Scaler, Ultrasonic

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    Other Clearances by Mti Precision Products

    K Number Device Name
    K070001 MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
    K960541 LYNX DPA DISPOSABLE PROPHY ANGLE
    K940261 LYNX LOW-SPEED HANDPIECE
    K895736 LYNX-HIGH SPEED HANDPIECE