Stratasys' TrueDent dental resins have received CE marking as a Class IIa medical devices.
Said to be Europe's first 'high-esthetic, monolithic 3D-printed denture solution to achieve certification', Stratasys believes the CE marking will enable broader clinical use and expand patient access to 3D printed dentures, crowns, bridges and intraoral removables for long-term use.
Stratasys' TrueDent-D was introduced in Europe in early 2025 under a CE Class I designation for denture production. While removable dentures are permitted under Class I, achieving CE Class IIa certification for TrueDent expands the indications and positions Stratasys to further penetrate the regulated European restorative market. It also gives dental labs, clinics, and patients even greater confidence in the validated biocompatibility, manufacturing controls, traceability and clinical safety and performance of the certified TrueDent resins.
“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. “By aligning TrueDent with the regulatory classification customers know and expect, we are providing additional clarity and confidence for clinicians and laboratories as they expand digital denture and temporary restoration workflows across the region.”
Under the European Medical Device Regulation (MDR), Class IIa devices are subject to an independent third-party oversight and heightened regulatory scrutiny. For laboratories and clinicians, this classification reflects the regulatory standard commonly expected for restorative dental materials, strengthening confidence in routine clinical use and supporting broader market adoption across the region.
Per 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 defined conversion kit enables existing customers to move seamlessly from TrueDent-D to TrueDent-certified resins, preserving established production processes and outcomes.
TrueDent resin colours include: TrueDent White, TrueDent Clear, TrueDent Cyan, TrueDent Magenta, TrueDent Yellow.
