Stratasys TrueDent Becomes Europe's First CE Class IIa Certified Monomer 3D Printed Denture Solution

Image Source: Stratasys Official Website

DentalGoodNews｜March 17, 2026 – 3D printing solutions provider Stratasys announced that its TrueDent® resin has received CE Class IIa certification, becoming the first monolithic 3D printed denture solution in Europe to achieve this certification. It can be applied to a market valued at over $2 billion (approximately RMB 13.774 billion). The company stated that this certification expands patient access to multi-color monolithic 3D printed dentures, removable partial dentures, as well as crowns and bridges.

According to the announcement, this certification expands the product's indications to include long-term intraoral removable prostheses for use exceeding 30 days, as well as crown and bridge restorations. It also allows dental laboratories to handle a broader range of restorative cases through a single, integrated digital workflow. TrueDent-D™ was launched in Europe in early 2025 with a CE Class I marking for denture production. The upgrade to Class IIa further expands its indications and strengthens the company's commercial foundation in the European restorative market.

Under the EU Medical Device Regulation (MDR), Class IIa devices are subject to independent third-party oversight and more stringent regulatory scrutiny. However, for laboratories and clinicians, this classification reflects the common regulatory standard for restorative dental materials, enhancing confidence in routine clinical applications and is expected to support the company's broader market adoption across the region. Chris Kabot, Vice President of Dental at Stratasys, stated that the CE Class IIa certification for TrueDent® is a significant milestone for the company and could support their continued expansion in the European dental business.

Transitioning to CE Class IIa does not require any changes to the print settings, formulations, workflow, or shelf life of the J5 DentaJet® printer platform. A defined conversion kit enables existing customers to seamlessly transition from TrueDent-D™ to the certified TrueDent® resin, preserving established production processes and outcomes. TrueDent® resin colors include White, Clear, Cyan, Magenta, and Yellow.

According to previous reports by DGN, Stratasys launched the DentaJet™ XL 3D printer for dental laboratories in 2024, which is claimed to reduce the cost per denture component by up to 67% and cut labor costs by approximately 90%. The company's revenue in 2023 was $630 million, with its dental business being a key growth driver for its 3D Additive Manufacturing.

According to the announcement, a 2024 iData report indicates that the demand for denture solutions in Europe continues to grow. The denture market in the region is projected to increase from $2.19 billion (approximately RMB 15.082 billion) in 2023 to $2.45 billion (approximately RMB 16.873 billion) by 2028.