3D Systems has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745, confirming its quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector.
Per 3D Systems, the EU MDR will immediately enable the introduction of 'innovative new materials' and is a 'pivotal step' for the NextDent Jetted Denture Solution, which is expected to be launched in Europe this summer. It will also form the cornerstone of the company's 'replacement' offering within its comprehensive digital dentistry strategy, spanning applications for straightening, protection, repair, and full replacement of teeth.
3D Systems believes the European rollout will allow it to capture 'additional share in a substantial global opportunity.' According to its internal estimates, applications for the ‘replacement’ pillar of 3D Systems' dental strategy represent an addressable market of approximately $600 million in the United States alone by 2029. The market in EU, 3D Systems expects, will be comparable - perhaps even slightly larger - in scale.
“Receiving full-scope EU MDR certification validates our commitment to the highest standards of quality and patient safety while unlocking significant new growth opportunities across the European dental market,” said Jeffrey Graves, President and Chief Executive Officer of 3D Systems. “Building on our established dominance in high-volume aligner production and the industry-leading NextDent materials portfolio from our Vertex acquisition, the NextDent Jetted Denture Solution represents a transformative advancement in delivering monolithic, multi-material prosthetics with superior aesthetics, durability, and production efficiency using our MultiJet Printing technology. With strong early traction in the U.S. and the substantial addressable market we outlined in our recent earnings call, this launch accelerates momentum in our dental business, one of our most significant growth initiatives, and reinforces its role as a key driver of long-term shareholder value. We are excited about these accomplishments and the substantial business opportunities they generate.”
Powered by the NextDent 300 MultiJet 3D printer and specialised NextDent Jet Base and Teeth materials, the NextDent Jetted Denture Solution enables dental labs to produce durable, aesthetically superior, one-piece dentures far faster and more cost-effectively than traditional analogue methods. It was introduced, and cleared by the FDA, last year.
