BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Guided Surgery Kit

    K Number: K231087 · Decision Aug 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    48
    Applicant Total
    17
    Review Days
    121

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    Basic Information

    Device Name
    Guided Surgery Kit
    K Number
    K231087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Implant Direct Sybron Manufacturing, LLC
    Date Received
    April 17, 2023
    Decision Date
    August 16, 2023
    Product Code
    DZI
    Advisory Committee
    Dental
    Review Advisory Committee
    HO
    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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