Key Takeaways
- 3D Systems' NextDent Jet Base and NextDent Jet Teeth materials, along with the NextDent 300 MultiJet 3D printer, have received EU Class IIa certification
- This certification enables commercialization of the NextDent Jetted Denture Solution across the EU
- The solution offers a monolithic, multi-material jetted denture workflow for dental labs
- The European denture segment represents a multi-billion-dollar opportunity
Introduction to 3D Systems' Certification
3D Systems has announced a significant regulatory milestone, achieving EU Class IIa certification for its NextDent Jet Base and NextDent Jet Teeth materials, as well as the NextDent 300 MultiJet 3D printer. This certification, granted under the European Union Medical Device Regulation (MDR 2017/745), allows for the immediate commercialization of the complete NextDent Jetted Denture Solution across the EU.
The NextDent Jetted Denture Solution
The NextDent Jetted Denture Solution is a groundbreaking, industry-first monolithic, multi-material jetted denture workflow. Powered by the NextDent 300 printer and the certified Jet Base and Jet Teeth materials, it enables dental labs to produce durable, highly aesthetic, patient-specific monolithic dentures in a single print. This innovative solution offers superior accuracy, consistency, and production speed compared to traditional analog methods.
Comparison of 3D Printing Technologies
| Technology | Material | Print Speed | Accuracy |
|---|---|---|---|
| NextDent 300 | Jet Base and Jet Teeth | Up to 10 mm/h | ± 0.1 mm |
| Traditional Analog | Various | Variable | ± 0.5 mm |
Market Opportunity and Availability
The European denture segment represents a significant market opportunity, with estimated revenues in the multi-billion-dollar range. With this certification, European customers can now access a complete, regulatory-compliant workflow, including hardware, certified materials, software, and application expertise, from a single trusted partner. The NextDent 300 MultiJet printer and associated NextDent Jet Base and Jet Teeth materials will be commercially available in EU markets starting May 4, 2026, through 3D Systems and its authorized distribution partners.
Bottom Line
In conclusion, 3D Systems' achievement of EU Class IIa certification for its NextDent Jetted Denture Solution marks a significant milestone in the company's leadership in the dental industry. With its innovative, monolithic, multi-material jetted denture workflow, 3D Systems is well-positioned to capitalize on the multi-billion-dollar European denture segment. The company's commitment to meeting Europe's stringent quality, safety, and clinical evidence requirements demonstrates its dedication to delivering high-quality, regulatory-compliant solutions to the dental industry.