Stratasys Ltd. (NASDAQ: SSYS) announced that its TrueDent resins received CE marking as a Class IIa medical device, becoming the first high-esthetic, monolithic 3D-printed denture solution to achieve this certification in Europe.

The certification expands the approved uses to include intraoral removables for long-term use of more than 30 days, as well as crowns and bridges. This allows dental laboratories to address a wider range of restorative cases through a single digital workflow.

Under the European Medical Device Regulation, Class IIa devices require independent third-party oversight and heightened regulatory scrutiny compared to Class I devices. The TrueDent-D product was previously available in Europe under CE Class I designation for denture production.

According to a 2024 iData report, the European denture market is projected to grow from $2.19 billion in 2023 to $2.45 billion by 2028.

"Achieving CE Class IIa certification for TrueDent is an important milestone and supports the continued expansion of our dental business in Europe," said Chris Kabot, Vice President Dental at Stratasys.

The transition to CE Class IIa requires no changes to print settings, formulation, workflow, or shelf life on the Stratasys J5 DentaJet printer platform. A conversion kit enables existing customers to move from TrueDent-D to the certified TrueDent resins.

TrueDent resin colors include White, Clear, Cyan, Magenta, and Yellow variants. The certification enables broader regulated clinical use for polychromatic, monolithic 3D-printed dentures, removable partial dentures, and crowns and bridges across European dental laboratories.