Align Technology Earns FDA Clearance for Dental Imaging System

March 25, 2020

Align Technology has received 510(k) clearance from the FDA for its Itero Element 5D dental imaging system.

The company said its full-color imager is the first to scan the internal structure of a tooth using near-infrared imaging technology.

In a single scan, the imager records a tooth’s enamel and tooth bulk in 3D intra-oral color and it can detect caries lesions above the gums without the use of radiation.

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