Stratasys has achieved CE Class IIa certification for its TrueDent resins portfolio. This designation makes it the first 3D-printed dental prosthesis system, based on a unique high-aesthetic material, to reach this regulatory level in Europe. The CE marking allows its commercialization and direct clinical use for definitive restorations.
A validated material and process 🦷
The certification covers the complete system: the TrueDent resins and the printing process on Stratasys PolyJet printers. Class IIa is a medium-risk classification for medical devices, indicating that the product is suitable for long-term restorations. This means the material has passed rigorous evaluations of biocompatibility, mechanical stability, and aging, complying with the European MDR regulation.
Goodbye to probably biocompatible 😅
This marks a turning point. No longer will we have to cross our fingers when explaining that the material should be safe for long-term oral use. Now, the documentation will include a CE Class IIa seal, which is basically the regulatory equivalent of yes, we tested it seriously. A relief for clinicians who preferred not to act as unwitting pioneers in biocompatibility trials with their patients.