The iTero Element 5D imaging system, which is now available commercially in the United States, records 3D data, intraoral color photos, and NIRI in a single scan and enables comparison overtime using iTero TimeLapse. 

Align Technology announced that the U.S. Food and Drug Administration (FDA) has cleared its iTero Element 5D imaging system for commercial availability in the United States. 

The iTero Element 5D expands the company’s existing full-color iTero Element intraoral scanner portfolio, with a system that it optimized for orthodontic and restorative dental workflows. This scanner’s visualization tools are designed to 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, helping to enable better patient education, engagement, and compliance during treatment. 

The iTero Element 5D intraoral scanner simultaneously records 3D data, intraoral color photos, and NIRI (near infrared images) and enables comparison over time using iTero TimeLapse. This imaging technology is designed to help doctors in detecting and monitoring the progression of interproximal caries above the gingiva without using radiation. This in turn helps patients receive improved care with visualization, education, and treatment acceptance. The iTero Element 5D imaging system allows doctors to scan patients at each visit to view a patient’s progress over time and together view treatment options. 

According to the company, surveyed doctors outside the United States who used the iTero Element 5D for at least 6 months reported increases in interproximal caries detection, patient acceptance, treatment recommendations, and practice revenue. 

The company reports that one full arch scan can be completed in as little as 60 seconds. The iTero Element 5D Imaging System includes NIRI, intraoral camera, 3D impressions for restorative and orthodontic work; analysis instruments, such as the Occlusogram occlusal clearance tool; iTero TimeLapse technology; and Invisalign Outcome Simulator and Progress Assistant. 

The U.S. Patent and Trademark Office issued the company two patents that cover the advanced features in the iTero Element 5D imaging system. One covers “Diagnostic Intraoral Scanning,” while the other is “Methods and Apparatuses for Forming a Three-Dimensional Volumetric Model of a Subject’s Teeth.” Additional patents covering other features are pending. 

The iTero Element 5D will be commercially available in the United States in the second quarter of 2020. It is currently available in Canada, Latin America, the European Union (EU) countries and EU EFTA countries, the United Kingdom, Australia, New Zealand, Hong Kong, Thailand, Japan, Korea, Singapore, and Taiwan. 

In a statement from Yuval Shaked, senior vice president and managing director for the company’s iTero scanner and services business, he acknowledged the current COVID-19 pandemic, saying the company is “mindful of the current environment and the impact that the COVID-19 pandemic is having across the world, and … focused solely on customer education regarding this new technology while so many dental practices in the U.S. are operating on a limited schedule.”