Dentium Co., Ltd., a specialized company in dental medical devices, announced that it has become the first in South Korea to obtain certification under the European Union's strengthened Medical Device Regulation (MDR). This certification applies to two of Dentium's products: the dental imaging equipment 'bright CT' and the hydraulic treatment chair 'bright Alone'. It is significant as it demonstrates that domestic medical device technology has passed the world's highest standards of safety and quality.

The MDR (European Medical Device Regulation) is a new medical device certification system implemented by the European Union since 2021, requiring much stricter product safety, clinical data, and manufacturing and quality management standards than previous regulations. Companies that pass this certification are recognized for the reliability and stability of their products in major markets worldwide, including Europe, and it is considered a key gateway for entry into the international medical device market. Dentium's achievement as the first in South Korea to obtain MDR certification is evaluated as objective evidence that domestic medical device technology has secured global-level quality and clinical reliability.

Dentium's hydraulic treatment chair 'bright Alone' is designed to allow dentists to perform treatments efficiently without the assistance of an assistant, as suggested by its name. The chair moves the lighting and suction devices in accordance with its operation, enabling stable and hygienic treatment independently.
It features a structure that remains stable even with prolonged use (Floor-Mount) and incorporates a detachable structure and internal cleaning system that facilitate easy cleaning and sterilization.

Dentium's dental imaging equipment 'bright CT' enhances clinical efficiency for dentists with high-resolution images and user-friendly operation. The 'rainbow 3D Viewer' program, developed by Dentium, integrates with bright CT to support precise diagnostics through AI technology, including implant procedure planning, nerve location identification, and bone structure analysis. This allows dentists to plan customized treatments for each patient more accurately.

Dentium plans to accelerate its efforts to penetrate the global market, including Europe, following the MDR certification. Under the slogan 'The NEXT in DIGITAL MINIMALISM', the company is pursuing a 'Digital Total Solution' that simplifies and enhances the efficiency of the entire dental treatment process through digital technology.

A representative from Dentium stated, "The MDR certification signifies that the safety and clinical reliability of Dentium's products are recognized globally," and added, "We will continue to innovate technology to enable medical professionals to provide safer and more efficient treatments."

Additionally, Dentium already provides an integrated solution that encompasses the entire dental treatment process, including implants, imaging equipment, chairs, and software. With this MDR certification, such technological capabilities are internationally recognized, and the global status of the domestic medical device industry is expected to be further elevated. Dentium declared, "We will continue to promote the excellence of Korean dental technology worldwide and create a digital treatment environment that both patients and medical professionals can trust."

Popular News