Osstem Implant announced on Friday that it has secured CE certification for its key dental X-ray products, including T2 Plus, T2, and N1, in compliance with the European Union (EU) Medical Device Regulation (MDR).
This certification officially confirms that these products meet the EU’s stringent safety, performance, and quality management standards, paving the way for expanded product distribution in the European market.
Dental X-ray equipment is essential in dental procedures, providing detailed images of patients’ teeth, alveolar bone, and oral structures for accurate diagnosis and treatment planning. The demand for precise imaging and consistent performance in this product category necessitates advanced technological expertise and rigorous quality control in the medical device industry.
With this latest certification, Osstem Implant has broadened its EU MDR-based CE certification to encompass diagnostic products. The company now holds CE certification for its entire range of in-house designed and manufactured products across diagnosis, treatment, and surgical procedures, including previously certified implants, prosthetics, dental surgical kits, digital guided surgery systems, and dental units (K3·K5).
Digital guided surgery employs surgical guides created from three dimensional (3D) imaging and digital data to ensure more precise implant placement.
The EU Medical Device Regulation (MDR), which supersedes the previous Medical Device Directive (MDD), is a comprehensive framework for evaluating medical devices’ safety, clinical efficacy, risk management, and manufacturing quality systems.
The MDR’s certification criteria are more rigorous than those of the MDD, making it a crucial requirement for medical device sales in the European market. It has also become a key benchmark for demonstrating product safety, quality, and regulatory compliance in the global medical device industry.
This certification achievement is particularly significant as it validates Osstem Implant’s capability to develop and produce essential products for the entire dental care process, from diagnosis to treatment, while meeting Europe’s enhanced medical device regulatory standards.
Osstem Implant is also bolstering its academic and educational initiatives in Europe. In June, the company hosted the well-received Osstem Europe Tour Seminar 2026, which brought together over 70 dentists and customers from nine European countries.
An Osstem Implant spokesperson stated that securing CE MDR certification for our core product lines in diagnosis, treatment, and care represents a significant milestone, demonstrating the quality competitiveness in the global market. It’s committed to further enhancing the brand credibility and influence in the European dental market.
