Home » News » Dentium obtains European MDR certification for the first time in Korea… “Medical device technology recognized by the world”|Dong-A Ilbo

Dentium obtains European MDR certification for the first time in Korea… “Medical device technology recognized by the world”|Dong-A Ilbo

Korean Dental Innovation Gains Global Recognition: Dentium’s ‘bright CT’ & ‘bright Alone’ Earn EU’s Highest Safety Mark

Seoul, South Korea – In a landmark achievement for Korean medical technology, Dentium Co., Ltd. has become the first company in the nation to secure certification under the European Union’s (EU) strengthened Medical Device Regulations (MDR) for two of its flagship products: the ‘bright CT’ dental imaging system and the ‘bright Alone’ hydraulic treatment chair. This isn’t just a win for Dentium; it’s a signal that Korean innovation is making waves on the world stage, and a potential game-changer for the future of dental care. This is breaking news for the dental industry and a significant boost for Korean exports.

What Makes the MDR Certification So Important?

The EU’s MDR, implemented in 2021, represents a significant leap forward in medical device safety and quality control. Unlike previous regulations, the MDR demands far more rigorous clinical data, manufacturing processes, and overall product safety assessments. Passing this certification isn’t simply about meeting a standard; it’s about demonstrating a commitment to patient safety and building trust in a highly regulated market. For companies aiming to expand into Europe – and beyond – MDR certification is quickly becoming a non-negotiable requirement. It’s a key indicator of reliability and stability, opening doors to international partnerships and market access. This is particularly relevant in today’s climate where consumers are increasingly focused on the provenance and safety of medical products.

‘bright Alone’: Redefining Dental Treatment Efficiency

Dentium’s ‘bright Alone’ hydraulic treatment chair isn’t just about comfort; it’s about empowering dentists to work more efficiently. Designed for solo operation, the chair features integrated lighting and suction systems that move in sync with the chair’s adjustments, ensuring a stable, hygienic, and streamlined treatment experience. Its robust floor-mount design minimizes shaking, while a detachable structure simplifies cleaning and sterilization. An internal cleaning system further enhances hygiene protocols. This addresses a growing need in dental practices – optimizing workflow and reducing the reliance on assistant personnel, especially in a challenging labor market.

‘bright CT’: AI-Powered Precision in Dental Imaging

The ‘bright CT’ dental imaging system is poised to revolutionize diagnostic accuracy. Delivering high-resolution images and a user-friendly interface, it significantly improves clinical efficiency. But the real innovation lies in Dentium’s self-developed ‘rainbow 3D Viewer’ program. This AI-powered software, seamlessly integrated with ‘bright CT’, provides precise diagnostic capabilities, including detailed implant treatment planning, accurate nerve location identification, and comprehensive bone structure analysis. This level of precision allows dentists to create truly customized treatment plans tailored to each patient’s unique anatomy and needs. The integration of AI is a key trend in modern dentistry, and Dentium is clearly at the forefront.

A Gateway to Global Expansion and the Future of Digital Dentistry

Dentium isn’t stopping here. The company plans to leverage this MDR certification to aggressively pursue global market opportunities, particularly in Europe. Under the banner of “The NEXT in DIGITAL MINIMALISM,” Dentium is championing a “Digital Total Solution” – a comprehensive approach that streamlines the entire dental treatment process through cutting-edge digital technology. This includes everything from implants and imaging equipment to chairs and sophisticated software solutions. The company’s vision is to create a digital treatment environment that is both trustworthy and efficient for both patients and medical professionals.

“This MDR certification signifies global recognition of the safety and clinical reliability of Dentium products,” stated a company official. “We are committed to continuous technological innovation to ensure medical staff can deliver safer and more effective treatment.” This achievement not only elevates Dentium’s position in the global market but also reinforces the growing reputation of Korean dental technology as a leader in innovation and quality. The impact of this certification will likely be felt throughout the industry, encouraging further investment and development in Korean medical device technology.

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