Stratasys TrueDent Dental Resins Achieve CE Class IIa Certification

A Regulatory Milestone for Dental 3D Printing

Stratasys has achieved a significant regulatory milestone for the dental 3D printing industry. The company's TrueDent dental resins have received CE marking as Class IIa medical devices—making it Europe's first high-esthetic, monolithic 3D-printed denture solution to achieve this certification.

What This Means

Previously, TrueDent-D was available in Europe under a CE Class I designation for denture production. While removable dentures are permitted under Class I, achieving Class IIa certification significantly expands the indications and positions Stratasys to penetrate the regulated European restorative market more deeply.

Under the European Medical Device Regulation (MDR), Class IIa devices are subject to independent third-party oversight and heightened regulatory scrutiny. This classification reflects the regulatory standard commonly expected for restorative dental materials, giving dental labs, clinics, and patients greater confidence in the validated biocompatibility, manufacturing controls, traceability, and clinical safety of the certified resins.

Expanding Patient Access

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.

"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."

No Changes Required

Importantly, 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, and TrueDent Yellow.