BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    EmbedMed

    K Number: K220366 · Decision Sep 30, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    234

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    Basic Information

    Device Name
    EmbedMed
    K Number
    K220366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D Lifeprints UK , Ltd.
    Date Received
    February 8, 2022
    Decision Date
    September 30, 2022
    Product Code
    DZJ
    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
    DZJ Driver, Wire, And Bone Drill, Manual

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    Other Clearances by 3D Lifeprints UK , Ltd.

    K Number Device Name
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