Ray's Dental Imaging Solution '5D' Receives U.S. FDA Certification

Ray announced on May 26 that it has obtained U.S. Food and Drug Administration (FDA) certification for its self-developed dental imaging diagnostic solution, '5D'.

With this certification, Ray has officially entered the North American market with the 5D solution, and has formally demonstrated its technological capabilities and reliability in the global imaging diagnostics market.

5D is a next-generation imaging diagnostic solution that allows anyone to easily understand and diagnose CT images. It automatically aligns various data acquired from CBCT, 3D facial scanners, and intraoral scanners. By visualizing anatomical structures such as the patient's nerve canals and tooth roots, it creates a three-dimensional patient model.

Artificial intelligence (AI) automatically reconstructs images optimized for diagnosis. Medical professionals can intuitively review treatment areas with patients and discuss treatment plans, such as implants, in advance.

Based on this FDA certification, Ray plans to accelerate the distribution and sales of the 5D solution within the United States.

The North American subsidiary, RayAmerica, achieved record sales growth in the first quarter, increasing by 3.2 times compared to the previous year. This demonstrated the success of its distribution network restructuring and the successful market entry of its new product, RayQuantum.

5D is expected to build on this momentum, maximize synergy with existing equipment, and play a key role in driving sales growth across the global market.

Meanwhile, the 5D solution was first unveiled at 'IDS 2025', the world's largest dental exhibition, held in Cologne, Germany, in March. It was introduced to more than 8,000 global dental professionals and distribution partners, receiving a highly positive response on site.