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ALIGN TECHNOLOGY RECEIVES FDA 510(K) CLEARANCE FOR THE ITERO ELEMENT 5D IMAGING SYSTEM IN THE U.S.
Seeing is believing: imaging and visualization capabilities of the iTero Element 5D Imaging System are designed to enable better patient engagement and lead
About this update from Align Technology, Inc.
[{"type":"text","content":"Seeing is believing: imaging and visualization capabilities of the iTero Element 5D Imaging System are designed to enable better patient engagement and lead to increased patient acceptance of recommended dental treatment\n\n \n \n \n \n \n \n \n \n \n \n \n The iTero Element 5D Imaging System is the first integrated dental imaging system that records 3D, intra-oral color and NIRI with a single scan, and enables comparison over time using iTero® TimeLapse. Data on file at Align Technology, as of December 4, 2018.\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n The iTero Element 5D Imaging System is the first integrated dental imaging system that records 3D, intra-oral color and NIRI with a single scan, and enables comparison over time using iTero® TimeLapse. Data on file at Align Technology, as of December 4, 2018.\n \n \n \n \n \n \n \n \n\n First intraoral scanner with near-infrared imaging (NIRI) technology that scans the internal structure of a tooth (enamel and dentin) in real time1.First integrated dental imaging system that records 3D, intra-oral color and NIRI with a single scan, and enables comparison over time using iTero® TimeLapse1 .NIRI technology of the iTero Element® 5D system aids in detection and monitoring of interproximal caries lesions above the gingiva without using harmful radiation1. SAN JOSE, Calif., March 24, 2020 (GLOBE NEWSWIRE) -- Align Technology, Inc. (NASDAQ: ALGN) today announced that the U.S. Food and Drug Administration (FDA) has cleared the award winning iTero Element 5D Imaging System for commercial availability in the United States. The iTero Element 5D Imaging System expands the suite of existing high-precision, 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, 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 patient education, engagement, and compliance during treatment. Commenting on today’s announcement, Yuval Shaked, Align Technology senior vice president and managing director, iTero scanner and services bu...