Quick Summary
• 3D printer OEM Stratasys has secured CE Class IIa medical device certification for its TrueDent resin portfolio, making it the first high-aesthetic, single-material 3D printed denture system to earn the designation in Europe. The upgrade from its initial Class I status, granted in early 2025, expands approved applications beyond basic removables to include removable partial […]
Additional Context
3D printer OEM Stratasys has secured CE Class IIa medical device certification for its TrueDent resin portfolio, making it the first high-aesthetic, single-material 3D printed denture system to earn the designation in Europe. The upgrade from its initial Class I status, granted in early 2025, expands approved applications beyond basic removables to include removable partial frameworks, and fixed crown and bridge restorations, opening new pathways for regulated clinical use across the continent.
The certification validates biocompatibility, manufacturing controls, traceability protocols, and clinical performance for laboratories, clinics, and patients.
“Achieving CE Class IIa certification for TrueDent is an important milestone and supports the continued expansion of our dental business i