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

    DENTAL HANDPIECES AND ATTACHMENT

    K Number: K864922 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    6
    Review Days
    65

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    Basic Information

    Device Name
    DENTAL HANDPIECES AND ATTACHMENT
    K Number
    K864922
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    E&D Dental Manufacturing Co.
    Date Received
    December 16, 1986
    Decision Date
    February 19, 1987
    Product Code
    EKS
    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
    EKS File, Pulp Canal, Endodontic

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