Kyozir Dental Zirconia Achieves EU MDR CE Certification (SGS NB1639) for CAD/CAM Systems

Kyozir announces that its dental zirconia materials have successfully obtained EU MDR CE certification issued by SGS (NB1639), marking an important step in the company’s regulatory compliance within the European market.

The certification confirms that Kyozir products comply with the requirements of the EU Medical Device Regulation (MDR 2017/745), one of the most stringent regulatory frameworks for medical devices worldwide. It covers product safety, performance, and full lifecycle quality management.

With this certification, Kyozir further strengthens its position as a supplier of dental zirconia blocks for CAD/CAM systems, supporting dental laboratories and distributors in global markets.

The MDR certification reflects Kyozir’s continued investment in research and development and its established quality management system aligned with European regulatory standards. It also enhances the company’s ability to provide consistent and reliable restorative materials for dental professionals and laboratories across Europe.

As a global provider of CAD/CAM dental solutions, Kyozir continues to expand its international presence.

With MDR certification in place, the company will continue focusing on product development and portfolio optimization, delivering reliable digital dentistry solutions to dental professionals worldwide.

Guided by the vision “Technology Serves Health, Technology Impacts the World” and the mission “Making Restorations More Natural, Making Treatments Easier”, Kyozir is committed to developing and supplying dental solutions for global markets.

Through continuous improvement and a long-term focus on quality, Kyozir aims to support the advancement of digital dentistry and contribute to better oral health outcomes worldwide.

Dental laboratories and distributors are welcome to request CE documentation, technical specifications, and sample kits for evaluation.

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