Dental Imaging Equipment ‘bright CT’ and Treatment Chair ‘bright Alone’ Pass Europe’s Highest Safety Standards
Global dental medical device specialist Dentium Co., Ltd. has obtained the European Union’s (EU) strengthened Medical Device Regulation (MDR) certification for the first time in Korea. This certification covers Dentium’s dental imaging equipment ‘bright CT’ and hydraulic treatment chair ‘bright Alone,’ holding great significance in that domestic medical device technology has passed the world’s highest level of safety and quality standards.
MDR (European Medical Device Regulation) is a new medical device certification system of the European Union implemented since 2021, requiring much stricter product safety, clinical data, and manufacturing/quality control standards than existing regulations. Companies that pass this certification are recognized for product reliability and stability in major global markets including Europe, and it is considered a key gateway for entering the international medical device market. Dentium’s acquisition of MDR certification for the first time in Korea 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,’ as the name suggests, is a product designed so that dentists can treat patients efficiently without the help of an assistant. By moving the lighting and suction devices in sync with the chair’s operation, stable and hygienic treatment is possible even alone. Also, by applying a structure (Floor-Mount) with no shaking even during long-term use and a detachable structure and internal cleaning system easy for cleaning and sterilization, it provides a hygienic and safe treatment environment for both medical staff and patients.
Dentium’s dental imaging equipment ‘bright CT’ enhances dentists’ clinical efficiency with high-resolution images and simple usability. Through this MDR certification, it has been officially confirmed that the equipment’s radiation safety, image quality, and manufacturing quality control level satisfy European standards.
The ‘rainbow 3D Viewer’ program independently developed by Dentium works in conjunction with bright CT to support precise diagnosis such as implant surgery planning, nerve location identification, and bone structure analysis through AI technology. Through this, dentists can plan patient-customized treatments more accurately.
Taking this MDR certification as momentum, Dentium plans to accelerate its targeting of global markets including Europe. Under the slogan ‘The NEXT in DIGITAL MINIMALISM,’ the company is promoting a ‘Digital Total Solution’ that simplifies and streamlines the entire dental treatment process with digital technology.
A Dentium official said, “This MDR certification means that the safety and clinical reliability of Dentium products have been recognized globally,” adding, “We will continue technological innovation so that medical staff can treat patients more safely and efficiently.”
In addition, Dentium already provides integrated solutions covering the entire dental treatment process including implants, imaging equipment, chairs, and software. With this MDR certification, such technical prowess is internationally accredited, and the global status of the domestic medical device industry is also expected to rise further. Dentium stated, “We will continue to let the world know the excellence of Korean dental technology and create a digital treatment environment that both patients and medical staff can trust.”