Osstem Implant Wins EU Certification for Dental X-ray Devices, Accelerates Push into European Market

[Financial News] Osstem Implant is accelerating its push into the European market after securing EU MDR-based CE certification for its key dental X-ray products. The company said on the 31st that it had completed CE certification under the EU MDR for its dental X-ray devices, including the 'T2 Plus', 'T2' and 'N1'.
The certification confirms that the products meet the European Union's requirements for safety, performance and quality management. It also gives the company a foundation for expanding local supply.
Dental X-ray devices are used to capture images of teeth, alveolar bone and other oral structures for disease diagnosis and treatment planning. Because they must deliver precise imaging and stable performance, they are considered a product category that depends heavily on a medical device maker's technology and quality control capabilities.
With this certification, Osstem Implant has expanded its EU MDR-based CE-certified portfolio into the diagnostics segment. As X-ray products are added to the company's previously certified implants, prosthetics, dental surgery kits, digital guided surgery systems and unit chairs (K3 and K5), it has strengthened its ability to respond to European regulations across the full dental care process, from diagnosis to treatment.
EU MDR is the European Union's medical device regulation, which replaced the former Medical Device Directive (MDD). It applies stricter standards than the MDD, taking into account safety, clinical performance, risk management and manufacturing quality systems in a comprehensive assessment.
It is a mandatory regulation for entering the European medical device market and is also used globally as a key benchmark for evaluating product quality and regulatory readiness.
Osstem Implant is also expanding its academic and training activities in Europe, in addition to product certification. In June, it hosted the 'Osstem Europe Tour Seminar 2026' and invited about 70 dentists and customers from nine European countries.
Participants visited the company's production facility in Busan and its headquarters in Seoul, where they observed the implant manufacturing process, quality control systems, digital dentistry solutions and clinical technologies firsthand.
Because Europe is a market with high medical standards and strict quality requirements, Osstem Implant plans to use the EU MDR certification as a foundation for expanding product supply across the region. It also intends to strengthen local academic and training programs and sales networks to raise both product competitiveness and brand awareness.
An Osstem Implant official said, "CE MDR certification for our core product lines in diagnostics, treatment and care is a result that once again proves our quality competitiveness in the global market." The official added, "Based on stronger product competitiveness, along with localized marketing and academic activities, we will expand brand trust and influence in the European dental market."
[email protected] Kang Jung-mo Reporter