BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    Fiber Optic Brushless Electronic Micromotor, model: iM100

    K Number: K231864 · Decision Mar 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    5
    Review Days
    259

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    Basic Information

    Device Name
    Fiber Optic Brushless Electronic Micromotor, model: iM100
    K Number
    K231864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codent Technical Industry Co., Ltd.
    Date Received
    June 26, 2023
    Decision Date
    March 11, 2024
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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