3D Systems erhält EU-MDR-Zertifizierung der Klasse IIa für die NextDent® Jetted Denture 3D Drucklösung und ermöglicht damit den vollständigenkommerziellen Start in Europa zwei Monate früher alsgeplant.

ROCK HILL, S.C., April 28, 2026: 3D Systems (NYSE: DDD) today announced that its NextDent® Jet Base and NextDent® Jet Teeth materials, together with the NextDent 300 MultiJet 3D printer, have received Class IIa certification under the European Union Medical Device Regulation (MDR 2017/745).

This regulatory milestone enables immediate commercialization of the complete NextDent Jetted Denture Solution across the EU.

This achievement builds directly on the Company’s full-scope EU MDR certification announced in March 2026 and demonstrates 3D Systems’ leadership in meeting Europe’s most stringent quality, safety, and clinical evidence requirements for moderate-risk medical devices.

The NextDent Jetted Denture Solution is the industry’s first monolithic, multi-material jetted denture workflow. Powered by the NextDent 300 printer and the newly certified Jet Base and Jet Teeth materials, it enables dental labs to produce durable, highly aesthetic, patient-specific monolithic dentures in a single print, fully cured and ready for finishing without additional post-curing steps. This breakthrough delivers superior accuracy, consistency, and production speed compared to traditional analog methods, reinforcing 3D Systems’ leadership across the full spectrum of dentistry: straighten, protect, repair, and replace.

Jeffrey Graves, Ph.D., President and Chief Executive Officer of 3D Systems, stated: “Achieving Class IIa MDR certification for our NextDent Jetted Denture Solution is a major milestone that validates the strength of our clinical data, quality systems, and innovation pipeline. By launching in Europe on May 4, well ahead of our original summer timeline, we are immediately expanding access to this transformative technology for dental labs and clinics across the region. This clearance substantially increases our available addressable market for this high-value platform. As adoption accelerates in both the U.S. and Europe, we expect it to drive significant recurring revenue through premium materials while reinforcing our position as the leading full-service provider in digital dentistry.”

According to internal estimates and market data, the European denture segment represents a multi-billion-dollar opportunity. With this certification, European customers can now access a complete, regulatory-compliant workflow, hardware, certified materials, software, and application expertise, from a single trusted partner.

The NextDent 300 MultiJet printer and associated NextDent Jet Base and Jet Teeth materials will be commercially available in EU markets beginning May 4, 2026, through 3D Systems and its authorized distribution partners.

For more information about the NextDent Jetted Denture Solution, visit: https://www.projet-3d-drucker.de/mjp-kunststoffdrucker/nextdent-300-mjp-dental/

About 3D Systems 

For nearly 40 years, 3D Systems has pioneered additive manufacturing solutions that transform how products are designed, prototyped, and produced. As a full-service solutions partner, the Company delivers industry-leading 3D printing technologies, materials, software, and expert application support to high-value markets including medical and dental, aerospace & defense, transportation, and durable goods. 

Forward-Looking Statements 

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the timing of product launches, regulatory approvals, market opportunities, expected revenue impact, and shareholder value. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise.

In diesem Webinar erhalten Sie alle Details zum NextDent 300 MultiJet 3D Drucker. Von der Technologie über Materialien bis zum Herstellungsprozess.

Die NextDent 300 MultiJet Drucker integrieren sich nahtlos in vorhandene digitale CAD/CAM‑Workflows und ermöglichen eine schnelle Individualisierung und Design‑Iteration, von Kleinserien bis hin zur hochvolumigen Prothesenfertigung.

Die hochmoderne, Multimaterial fähige MJP Jetting‑Technologie und der vollautomatisierte Workflow ermöglichen es Laboren, Prothesen in etwa 12 Stunden Gesamtproduktionszeit herzustellen und dies ohne Einbußen bei der Qualität.

Die Möglichkeit, monolithische Prothesen mit nahtlos verbunden Materialien zu drucken, sorgt für eine natürliche Ästhetik, hohe Bruchfestigkeit und ein sehr realistisches Erscheinungsbild, was zu einer höheren Patientenzufriedenheit führt.

Die MJP MultiJet Jetted Denture Drucker von 3D Systems bieten eine schnellere, kosteneffizientere und hoch skalierbare Alternative zur konventionellen Prothesenfertigung und unterstützt Labore bei besseren wirtschaftlichen Ergebnissen und führt zu besseren Versorgungsresultaten für Patienten.

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Ihr KISTERS 3D Systems Team Deutschland

02408/9385-560     |   [email protected]