[Edaily Reporter KIM SAE-MI ] DIO Corporation(039840)announced on the 23rd that its new products, “SICON” and “Prism X,” have obtained certification under the European Medical Device Regulation (MDR).

With this certification, DIO Corporation has secured the regulatory foundation for entering the European market with SICON and Prism X, following the launch of “UNICON” last year. The European MDR stipulates safety and performance management requirements for the entire product lifecycle, from the design and development of medical devices to manufacturing, clinical evaluation, risk management, and post-market surveillance (PMS).

Sicon is an implant developed to address challenging clinical environments such as the maxillary sinus, soft bone, and immediate placement and loading. It features an 11-degree connection design, allowing prosthetics to be used in a single size regardless of fixture diameter. It was first launched in South Korea last May.

Prism X is a product that utilizes the 8-degree connection system, which is highly preferred in the European market. It was developed to enable efficient implant placement and prosthetic restoration in “All-on-X” treatments for edentulous patients by utilizing a titanium base (Ti-base) and multi-unit abutments. Prism X will be unveiled for the first time at the “DIO Corporation International Meeting (DIM),” to be held at COEX in Seoul on the 10th and 11th of next month.

DIO Corporation plans to expand its market share by competing with European and U.S.-made implant products using Prism X as its flagship product. Based on this MDR certification, the company also plans to pursue global certifications for Prism X in stages.

Kim Jong-won, CEO of DIO Corporation, said, “We expect ‘Unicorn,’ our next-generation flagship product launched in Korea last year, to obtain certification in China and be launched there within this year,” adding, “We will continue to develop new products capable of meeting the diverse demands of the global market.”