3D Systems (NYSE: DDD) received full-scope certification under the European Union Medical Device Regulation on March 17, 2026, the company announced. The certification enables the company to introduce medical device regulation-compliant product versions across its dental product families in European markets.

The certification allows 3D Systems to launch its NextDent Jetted Denture Solution in Europe during summer 2026. The company previously launched the product commercially in the United States in 2025.

According to company estimates, applications for dental replacement represent an addressable market of approximately $600 million in the United States by 2029, with the U.S. comprising roughly one-third of the total global market. The company estimates the EU market to be comparable or larger than the U.S. market.

Chief Executive Officer Jeffrey Graves stated that approximately 32 million people in the United States wear dentures, representing about 10% of the population. Globally, more than 180 million people wear dentures, driving annual production of approximately 13.7 million denture sets.

The NextDent Jetted Denture Solution uses the NextDent 300 MultiJet 3D printer with specialized NextDent Jet Base and Teeth materials. The system enables dental laboratories to produce one-piece dentures using 3D printing technology.

3D Systems acquired Vertex Global Holding B.V. in 2017, which combined Vertex Dental's prosthetic dental materials business with NextDent's biocompatible 3D printing resins. NextDent was originally launched in 2012 to develop materials for 3D printing applications in dentistry.