3D Systems Corporation (NYSE: DDD) received Class IIa certification under the European Union Medical Device Regulation for its NextDent Jetted Denture Solution, the company announced. The certification allows commercial launch across EU markets beginning May 4, 2026, two months ahead of the previously planned summer timeline.

The certified solution includes NextDent Jet Base and NextDent Jet Teeth materials along with the NextDent 300 MultiJet 3D printer. The system enables dental laboratories to produce patient-specific dentures in a single print without additional post-curing steps, according to the company.

The certification follows 3D Systems' full-scope EU MDR certification announced in March 2026. Class IIa designation applies to moderate-risk medical devices under European regulations.

"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," said Jeffrey Graves, president and chief executive officer of 3D Systems.

The company stated the European denture market represents a multi-billion dollar opportunity. With EU certification, the addressable market for the dental printing platform expands to over 60 million edentulous patients across the United States and European Union.

3D Systems reported positive feedback from the U.S. market launch regarding patient satisfaction with denture aesthetics, comfort and performance using NextDent 300 technology. The NextDent 300 printer and associated materials will be available through 3D Systems and authorized distribution partners starting May 4, 2026.