3D Systems has secured Class IIa certification under the EU Medical Device Regulation (MDR 2017/745) for its NextDent Jetted Denture Solution, clearing the way for a full European commercial launch, two months earlier than originally planned.
The certification covers the NextDent Jet Base and NextDent Jet Teeth materials, used in conjunction with the NextDent 300 MultiJet 3D printer. Together, they form what the company describes as the industry’s first monolithic, multi-material jetted denture workflow, enabling dental labs to produce patient-specific dentures in a single print, fully cured and ready for finishing, without additional post-curing steps.
The milestone builds on 3D Systems’ full-scope EU MDR certification announced in March 2026 and signals the company’s ability to meet Europe’s stringent requirements for moderate-risk medical devices. With this regulatory clearance, European customers gain access to a complete, compliant workflow (hardware, certified materials, software, and application expertise) from a single provider.
The market opportunity is significant. The certification expands the addressable market for the company’s flagship dental printing platform to over 60 million edentulous patients across the US and EU, representing a multi-billion dollar denture market.
Jeffrey Graves, President and CEO of 3D Systems, underscored the strategic weight of the achievement: “Achieving Class IIa MDR certification for our NextDent Jetted Denture Solution is a major milestone that validates the strength of our clinical data, quality systems, and innovation pipeline. By launching in Europe on May 4, well ahead of our original summer timeline, we are immediately expanding access to this transformative technology for dental labs and clinics across the region.”
Early feedback from the U.S. launch, where the solution has already been commercially available, points to strong patient satisfaction in terms of aesthetics, comfort, and performance.
For 3D Systems, this certification reinforces its positioning across what it calls the full spectrum of dentistry: straighten, protect, repair, and replace.
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