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510(k) Data Aggregation

    K Number
    K131101
    Device Name
    ITERO SOFTWARE
    Manufacturer
    CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY
    Date Cleared
    2013-08-26

    (129 days)

    Product Code
    NHA, NOF
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CADENT, LTD. AN ALIGN TECHNOLOGY COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.
    Device Description
    The iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. The software supports dental professionals in acquiring very accurate digital images which can be edited and used for planning and simulation. The software controls the export of the data by a secured internet connection for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories.
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