3D Systems Receives EU MDR Clearance, Unlocking European Denture Market

3D Systems has been fully certified under the European Union Medical Device Regulation (EU MDR) 2017/745, clearing the bloc's most demanding standard for quality systems, technical documentation, and clinical evidence. This clears the way for the European launch of the NextDent Jetted Denture Solution, a system that lets dental laboratories produce single-piece multi-material dentures more quickly and at lower cost than conventional analog workflows. The European denture market is pegged as comparable in size to the U.S. market, or potentially larger, making the regulatory green light a meaningful revenue unlock.