BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    iTero Lumina™ Pro

    K Number: K240573 · Decision Aug 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    168

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    Basic Information

    Device Name
    iTero Lumina™ Pro
    K Number
    K240573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1745
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Align Technology , Ltd.
    Date Received
    March 1, 2024
    Decision Date
    August 16, 2024
    Product Code
    NTK
    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
    NTK Caries Detector, Laser Light, Transmission

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