DAEGU, South Korea: MegaGen has expanded its portfolio of products certified under Regulation (EU) 2017/745—the EU Medical Device Regulation (MDR)—to encompass implant systems, dental treatment equipment and digital diagnostic devices. The latest addition is R2 Studio Q. This advanced imaging system combines CBCT, panoramic and cephalometric imaging in a single platform and integrates with MegaGen’s R2GATE digital workflow for implant planning.
MegaGen has also obtained MDR certification for the R2i5 intra-oral scanner, the R2 Photogram photogrammetry system for recording implant positions in full-arch cases, and its digital maxillofacial solutions. Together, these certifications extend MegaGen’s MDR-certified portfolio across several stages of the digital workflow, including diagnosis, data acquisition, treatment planning and clinical procedures.
MegaGen has progressively expanded its MDR-certified portfolio since obtaining certification for the XPEED AnyRidge internal implant system in 2022. It subsequently added the AnyOne Internal, ARi and BD Cuff implant systems, as well as the AXA abutment and N2 chair. This brought the number of MDR-certified product lines to six, encompassing implant systems and associated surgical kits, an implant abutment system and a dental chair unit.
MegaGen began preparing early for the transition to the MDR by developing its clinical evaluation processes, reorganising its technical documentation and strengthening its post-market surveillance and post-market clinical follow-up strategies. The company said that these measures will also support future product modifications and additions to its portfolio and that it will continue to strengthen its competitiveness in the digital dentistry market by building on quality and technological capabilities that meet global regulatory standards.
MegaGen exports to more than 100 countries. According to export statistics cited by the company, it ranked first among South Korean implant companies in exports to Europe for 13 consecutive years up to and including 2025 and in exports to the US for five years between 2020 and 2025. More information about MegaGen can be found on the company’s website.
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