FDA Clears Imaging System for Commercial Availability

Richard Gawel


The US Food and Drug Administration has cleared Align Technology’s iTero Element 5 Imaging System for commercial availability. According to the company, the system expands the iTero Element suite’s full-color imaging and fast scan times with a new clinical approach, optimized orthodontic and restorative dental workflows, and an improved doctor experience.

Also, Align Technology says, the iTero Element 5D Imaging System visualization tools improve patient engagement and communication by helping patients see and better understand their current dental health, their treatment plan options, and prescribed outcome on the iTero touchscreen, enabling better education, engagement, and compliance during treatment.

“The iTero Element 5D Imaging System seamlessly combines three scanning technologies (3-D data, intraoral color photos, and NIRI images) into one integrated scan, and we are excited to bring this advancement in intraoral scanner technology to the US market to help doctors provide better oral care for their patients,” said Yuval Shaked, Align Technology senior vice president and managing director, iTero scanner and services business. 

“At the same time, we are mindful of the current environment and the impact that the COVID-19 pandemic is having across the world and are focused solely on customer education regarding this new technology while so many dental practices in the US are operating on a limited schedule,” said Shaked.

The iTero Element 5D scanner is the first integrated dental imaging system that simultaneously records 3-D, intraoral color, and near-infrared (NIRI) images and enables comparison over time using iTero TimeLapse, the company says.

The system’s integrated 3-D, intraoral color, and NIRI technology helps doctors detect and monitor the progression of interproximal caries above the gingival without using harmful radiation, Align Technology says, helping to ensure that their patients receive even better care with visualization, education, and treatment acceptance.

Align Technology says the diagnosis of caries, especially interproximal lesions or those between teeth, can be hampered by several factors including variations in the shape and alignment of teeth, traditional limitations of x-ray examinations that include variability in exposure level, bad angulations in the captured image, or overlapping contacts in the image, among other factors.

With the iTero Element 5D Imaging System, the company adds, doctors can scan patients at each visit to view a patient’s progress over time and together view treatment options that result in clearer decisions for better care. 

A survey of doctors outside of the United States who had used the iTero Element 5D Imaging System for at least six months reported increases in interproximal caries detection, patient acceptance of treatment recommendations, and practice revenue, Align Technology says.

According to the company, with one full arch scan completed in as little as 60 seconds, the system provides powerful visualization capabilities including:

  • NIRI
  • Intraoral camera
  • 3-D impressions for restorative and orthodontic work
  • Analysis instruments such as the Occlusogram occlusal clearance tool
  • iTero TimeLapse technology
  • Invisalign Outcome Simulator and Progress Assessment

The iTero Element 5D Imaging System will be commercially available in the United States in the second quarter of 2020.

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