iTero Element 5D Imaging System from Align Technology Receives FDA Approval

 iTero Element 5D Imaging System from Align Technology Receives FDA Approval

Align Technology’s iTero Element 5D imaging system recently received clearance from the U.S. Food and Drug Administration (FDA) and is now available in the U.S., expanding the company’s line of high-precision, full-color intraoral scanners.

The system is designed to enable better patient engagement for increased case acceptance, according to a press release.

The intraoral scanner features near-infrared imaging (NIRI) technology that scans the internal structure of a tooth in real time. It also offers a new clinical approach, optimized orthodontic and restorative workflows, and an improved doctor experience.

The system’s visualization tools improve patient engagement and communication by helping patients see and better understand their dental health, treatment plan options and prescribed outcome on the iTero touchscreen. This enables improved patient education, engagement, and compliance during treatment.

The iTero Element 5D integrated dental imaging system simultaneously records 3D, intraoral color and NIRI images and enables comparison over time using iTero TimeLapse. This integration helps clinicians detect and monitor the progression of interproximal caries above the gingiva without using radiation.

Diagnosing caries, especially interproximal lesions, can be hampered by several factors, including variations in the shape and alignment of teeth, x-ray limitations that include variability in exposure level, bad angulations in the captured image, or overlapping contacts in the image. With this system, dentists can scan patients at each visit to view progress over time and view treatment options with them that result in clearer decisions for better clinical care. 

The iTero Element 5D Imaging System will be commercially available in the United States in the second quarter. It is currently available in Canada, Latin America, European Union (EU) countries and EU EFTA countries, the United Kingdom, Australia, New Zealand, Hong Kong, Thailand, Japan, Korea, Singapore and Taiwan.

View Full Press Release

Source: Align Technology

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