iTero (Various models) - Intraoral optical scanning system

Intended purpose

For use as an intra-oral scanner with the following features and intended purpose/indications for use: - The optical impression (CAD/CAM) feature of the scanner is intended/indicated for use to record the topographical images of teeth, oral tissue and bite relationship. Data generated from iTero may be used in conjunction with the production of dental devices (e.g. aligners, braces, appliances, etc.) and accessories. - 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 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. - Some models may provide / be upgraded / be enabled with a near infra-red imaging (NIRI) functionality, which is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions, including kits to upgrade between various models.