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

    Surgical Drive System (Model: ES70, ES90, E8)

    K Number: K240340 · Decision Jul 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    4
    Review Days
    164

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    Basic Information

    Device Name
    Surgical Drive System (Model: ES70, ES90, E8)
    K Number
    K240340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Jinme Medical Technology Co., Ltd.
    Date Received
    February 5, 2024
    Decision Date
    July 18, 2024
    Product Code
    DZI
    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
    DZI Drill, Bone, Powered

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