ROCK HILL, SC, USA, May 1, 2026 – 3D Systems (NYSE: DDD) announced that its NextDent Jet Base and NextDent Jet Teeth materials, together with the NextDent 300 MultiJet 3D printer, have received Class IIa certification under the European Union Medical Device Regulation (MDR 2017/745). This regulatory milestone enables immediate commercialization of the complete NextDent Jetted Denture Solution across the EU.
This achievement builds directly on the Company’s full-scope EU MDR certification announced in March 2026 and demonstrates 3D Systems’ leadership in meeting Europe’s most stringent quality, safety, and clinical evidence requirements for moderate-risk medical devices.
The NextDent Jetted Denture Solution is the industry’s first monolithic, multi-material jetted denture workflow. Powered by the NextDent 300 printer and the newly certified Jet Base and Jet Teeth materials, it enables dental labs to produce durable, highly aesthetic, patient-specific monolithic dentures in a single print, fully cured and ready for finishing without additional post-curing steps. This breakthrough delivers superior accuracy, consistency, and production speed compared to traditional analog methods, reinforcing 3D Systems’ leadership across the full spectrum of dentistry: straighten, protect, repair, and replace.
Jeffrey Graves, Ph.D., President and Chief Executive Officer of 3D Systems, stated: “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. This clearance substantially increases our available addressable market for this high-value platform. As adoption accelerates in both the U.S. and Europe, we expect it to drive significant recurring revenue through premium materials while reinforcing our position as the leading full-service provider in digital dentistry.”
According to internal estimates and market data, the European denture segment represents a multi-billion-dollar opportunity. With this certification, European customers can now access a complete, regulatory-compliant workflow, hardware, certified materials, software, and application expertise, from a single trusted partner.
Availability
The NextDent 300 MultiJet printer and associated NextDent Jet Base and Jet Teeth materials will be commercially available in EU markets beginning May 4, 2026, through 3D Systems and its authorized distribution partners.
For more information about the NextDent Jetted Denture Solution, visit: www.3dsystems.com/dental-jetted-dentures
About 3D Systems
For nearly 40 years, 3D Systems has pioneered additive manufacturing solutions that transform how products are designed, prototyped, and produced. As a full-service solutions partner, the Company delivers industry-leading 3D printing technologies, materials, software, and expert application support to high-value markets including medical and dental, aerospace & defense, transportation, and durable goods. More information is available at www.3dsystems.com.
