Stratasys is pleased to announce that TrueDent® resins have received CE Class IIa medical device certification under the European Medical Device Regulation (EU MDR) 2017/745. The certification was granted by our Notified Body, TÜV SÜD, and marks a significant regulatory milestone for TrueDent in Europe.
For dental labs, clinicians, and their patients across Europe, this means one thing above all: the 3D printed TrueDent dentures, partial dentures, crowns, and bridges they depend on are now backed by the highest standard of EU regulatory validation for restorative dental materials.
Under the EU Medical Device Regulation, medical devices are classified based on their level of risk and intended use. Class IIa applies to medium-risk devices and requires independent, third-party oversight by a Notified Body — in this case, TÜV SÜD, one of Europe's most recognized conformity assessment bodies.
For dental materials intended for long-term intraoral use (more than 30 days), CE Class IIa is the regulatory classification that clinicians, dental labs, and procurement bodies across Europe commonly expect. Achieving this designation means that TrueDent has met the more rigorous standards of review, documentation, biocompatibility testing, and manufacturing controls required under MDR 2017/745.
TrueDent's CE Class IIa certification reflects expanded indications for use, including:
All are intended for long-term intraoral use (greater than 30 days) in adult patients.
This expanded scope allows dental laboratories to address a wider range of restorative needs through a single, integrated digital denture workflow — without switching materials or platforms.
One of the most practical aspects of this certification is what it does not require you to change your workflow. The transition from TrueDent-D (Class I) to TrueDent (Class IIa) involves no changes to:
The only change is the regulatory designation and the higher level of validated confidence that comes with it. New part numbers apply to the CE Class IIa product line (see ordering information below).
TrueDent is produced on the Stratasys J5 DentaJet, the PolyJet 3D printer for dental labs. The J5 DentaJet produces polychromatic, monolithic dentures by simultaneously jetting five base color materials in a single print — delivering lifelike aesthetics and natural color gradations without the manual layering or post-processing required in conventional workflows.
CE Class IIa certification further strengthens the case for labs that have been evaluating TrueDent as a replacement for traditional denture fabrication methods. The combination of regulatory approval, clinical-grade biocompatibility, and a fully digital end-to-end workflow makes TrueDent a compelling option for labs ready to scale production.
To place an order, contact your supplier using the new part numbers below:
For labs currently using TrueDent-D, a Conversion Kit (OBJ-09192-V) is available and includes the cleanser required when transitioning between materials on the J5 DentaJet. Please refer to the J5 DentaJet User Guide (DOC09270) for full instructions. Be sure all personnel review the updated Safety Data Sheets (SDS) and Instructions for Use (IFU) prior to use.
It means TrueDent is now classified as a medium-risk medical device under EU MDR 2017/745, subject to independent third-party oversight by TÜV SÜD. This designation aligns TrueDent with the regulatory standard commonly expected for dental materials intended for long-term intraoral use, giving labs and clinicians greater confidence in its safety, performance, and biocompatibility.
No. The resin formulation, print settings, workflows, and output quality remain identical. CE Class IIa is a regulatory classification change, not a product change.
No. Workflow revalidation is not required. Print settings and material performance are unchanged.
Yes. Existing TrueDent-D stock may be depleted. Due to a change in medical device classification, TrueDent-D and TrueDent should not be printed simultaneously; use the cleanser provided in the Conversion Kit between materials (refer to DOC09270).
The new SKUs are:
A Conversion Kit (OBJ-09192-V) is exclusively available for labs transitioning from TrueDent-D to TrueDent
No. Pricing remains the same.
No. TrueDent retains its 2-year shelf life.
TrueDent (Class IIa) covers removable full and partial dentures, denture bases, denture teeth, temporary crowns, and bridges — all intended for long-term intraoral use exceeding 30 days.
Contact your Stratasys salesperson or customer support representative. You can also reach the dental team directly at dental@stratasys.com.
CE Class IIa certification is specific to European markets under EU MDR 2017/745. TrueDent is available in additional markets subject to applicable regional regulatory clearances and approvals. Contact your local Stratasys representative for details.
