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

    PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES

    K Number: K083101 · Decision Feb 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    2
    Review Days
    126

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    Basic Information

    Device Name
    PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
    K Number
    K083101
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sable Industries, Inc.
    Date Received
    October 20, 2008
    Decision Date
    February 23, 2009
    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 Sable Industries, Inc.

    K Number Device Name
    K072554 ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES