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510(k) Data Aggregation

    K Number
    K240573
    Device Name
    iTero Lumina™ Pro
    Manufacturer
    Align Technology Ltd.
    Date Cleared
    2024-08-16

    (168 days)

    Product Code
    NTK, OJK
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    Align Technology Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
    Device Description
    The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images. The iTero Lumina Pro consists of the following main components: - A. Scanning Wand used for intraoral scanning. - B. Wand Cradle used to hold the Scanning Wand when not in use. - C. Application Software that includes Graphical User Interface ("GUI"). - D. Computer platform The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle. The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export. The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.
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