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

    DAWN LOW SPEED HANDPIECE SYSTEM

    K Number: K821484 · Decision Jun 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    16
    Review Days
    22

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    Basic Information

    Device Name
    DAWN LOW SPEED HANDPIECE SYSTEM
    K Number
    K821484
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    May 18, 1982
    Decision Date
    June 9, 1982
    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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