BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Endo Ultrasonic Activator

    K Number: K222096 · Decision Mar 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    194
    Applicant Total
    7
    Review Days
    248

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    Basic Information

    Device Name
    Endo Ultrasonic Activator
    K Number
    K222096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4850
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Foshan Coxo Medical Instrument Co., Ltd.
    Date Received
    July 18, 2022
    Decision Date
    March 23, 2023
    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 Foshan Coxo Medical Instrument Co., Ltd.

    K Number Device Name
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    K220831 Dental Implantation Systems, Dental Electrical Motors
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