Align Technology Receives FDA 510(K) Clearance for iTero Element 5D Imaging System

Posted: March 30, 2020
Edited by Dentaltown staff

SAN JOSE, Calif.—Align Technology announced that the U.S. Food and Drug Administration (FDA) has cleared the iTero Element 5D imaging system for commercial availability in the United States. The system expands the suite of existing full-color imaging and fast scan times of the iTero Element intraoral scanner portfolio with a new clinical approach, optimized orthodontic and restorative dental workflows, and an improved doctor experience. In addition, system'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, enabling better patient education, engagement, and compliance during treatment.

“The iTero Element 5D Imaging System seamlessly combines three key scanning technologies (3D 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 U.S. market to help doctors provide better oral care for their patients. 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 U.S. are operating on a limited schedule," said Yuval Shaked, Align Technology senior vice president and managing director, iTero scanner and services business. 

With one full arch scan, completed in as little as 60 seconds, the iTero Element 5D imaging system provides doctors with:

- NIRI (near infrared image)
- Intraoral camera
- 3D 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 and 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.

For more information, visit itero.com/en/products/itero_element_5d.  
Views: 377
Sponsors
Townie Perks
Townie® Poll
Who or what do you turn to for most financial advice regarding your practice?
  
The Dentaltown Team, Farran Media Support
Phone: +1-480-445-9710
Email: support@farranmedia.com
©2025 Dentaltown, a division of Farran Media • All Rights Reserved
9633 S. 48th Street Suite 200 • Phoenix, AZ 85044 • Phone:+1-480-598-0001 • Fax:+1-480-598-3450