1.1
Intended purpose/Intended use
The iTero Element 5D and iTero Element 5D Plus imaging systems are intraoral scanners with the following
features and intended use:
l
The optical impression (CAD/CAM) feature of the scanner is intended/indicated for use to record the
topographical images of teeth and oral tissue. Data generated from iTero may be used in conjunction with the
production of dental devices (e.g. aligners, braces, appliances, etc.) and accessories.
l
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.
l
The iTero Element 5D NIRI functionality is a diagnostic aid for the detection of interproximal carious lesions
above the gingiva and for monitoring the progress of such lesions.
1.2
Indications for use
iTero Element scanners are indicated for use for orthodontic treatment planning and follow-up, restorative
treatment plan and/or routine dental assessment.
1.3
Contraindications
For persons who have been diagnosed with Epilepsy, there is a risk of epileptic shock from the flashing light of the
iTero scanner. These persons should refrain from any eye contact with the flashing light associated with the
system during operation.
1.4
Intended patient population
The system may be used on patients classified as Preadolescent, Adolescent, and Adult.
1.5
Intended users
The system serves as a prescription medical device and should be operated by trained health-care providers only.
1.6
Use environment
Professional Healthcare and Home Healthcare Facility environment.
iTero Element 5D and iTero Element 5D Plus imaging systems User manual
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