Stratasys TrueDent Dental Resins Attain CE Class IIa

Stratasys, a renowned leader in 3D printing technology, has achieved a significant milestone with its TrueDent dental resins, now proudly certified as CE Class IIa medical devices. This achievement marks the first instance of a high-aesthetic monolithic 3D-printed denture solution obtaining such certification in Europe. This regulatory advancement is poised to broaden clinical adoption and enhance access to state-of-the-art dental care for patients across Europe. 

The recent certification of TrueDent resins as Class IIa under the European Medical Device Regulation signifies critical progress for Stratasys. Unlike their initial introduction under the Class I designation, this new status permits a wider range of applications, including dentures, crowns, bridges, and intraoral removable devices intended for extended use. The Class IIa classification requires rigorous independent third-party evaluation and more stringent oversight, aligning with the sector’s expectations for dental restorative materials. This move is anticipated to bolster confidence among dental laboratories and clinicians, endorsing the product’s biocompatibility, manufacturing controls, and clinical safety. Significant for existing users, the transition to certified resins requires no changes in print settings or workflow, maintaining seamless production processes. Stratasys offers an easy conversion kit to facilitate this upgrade.

Stratasys’ advancement in obtaining CE Class IIa certification for TrueDent dental resins highlights its commitment to quality and safety in dental prosthetics. This development is a promising stride towards greater market penetration, ensuring that patients across Europe benefit from cutting-edge, long-term dental solutions with enhanced accessibility.