3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 2026

ROCK HILL, S.C., March 25, 2026 (GLOBE NEWSWIRE) -- 3D Systems (NYSE:DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 17, 2026.

This milestone confirms that the Company's quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers.

The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Systems' largest potential new product launches: the NextDent® Jetted Denture Solution. This solution forms the cornerstone of the Company's ‘replacement' offering within its comprehensive digital dentistry strategy, which spans applications for straightening, protection, repair, and full replacement of teeth.

Building on the successful U.S. commercial launch in 2025, this European rollout positions 3D Systems to capture additional share in a substantial global opportunity. According to the Company's internal estimates, applications for the ‘replacement' pillar of its dental strategy represent an addressable market of approximately $600 million in the United States alone by 2029, with the U.S. comprising roughly one-third of the total global market. The market in the EU is estimated to be comparable, or even slightly larger in scale than that of the U.S., based on Company analysis and demographic trends. As highlighted by President and CEO, Dr. Jeffrey Graves, during the Company's Q4 2025 earnings call on March 9, 2026, approximately 32 million people in the United States wear dentures, roughly 10% of the population, and globally more than 180 million people wear dentures, driving annual production of approximately 13.7 million denture sets. Management further noted that 3D Systems' materials alone represent a potential annual recurring revenue opportunity of more than $400 million globally over time, as digital manufacturing adoption accelerates.

The European launch of NextDent Jetted Dentures remains firmly on track for summer 2026.

3D Systems has long held a leadership position in digital dentistry, particularly in orthodontic aligner production.

Through its longstanding partnership with major industry players and the deployment of application specific high-volume manufacturing stereolithography (SLA) technology, the Company's solutions enable the manufacture of approximately one million patient-specific clear aligners daily worldwide, establishing it as a key enabler in the straightening segment of the market.

This leadership builds on the 2017 acquisition of Vertex Global Holding B.V., which brought together Vertex Dental's decades-long legacy in high-quality prosthetic dental materials (dating back to its founding in 1939) with NextDent's pioneering biocompatible 3D printing resins. NextDent, originally launched in 2012 to advance materials for emerging 3D printing innovations in dentistry, has since developed one of the industry's broadest portfolios of clinically validated, regulatory-approved materials, addressing applications from models and surgical guides to splints, crowns, bridges, and dentures. The integration of these advanced Vertex and NextDent materials with 3D Systems' printing platforms has driven transformative efficiency, precision, and cost reductions across dental workflows.

"Receiving full-scope EU MDR certification validates our commitment to the highest standards of quality and patient safety while unlocking significant new growth opportunities across the European dental market," said Jeffrey Graves, President and Chief Executive Officer of 3D Systems. "Building on our established dominance in high-volume aligner production and the industry-leading NextDent materials portfolio from our Vertex acquisition, the NextDent Jetted Denture Solution represents a transformative advancement in delivering monolithic, multi-material prosthetics with superior aesthetics, durability, and production efficiency using our MultiJet Printing technology. With strong early traction in the U.S. and the substantial addressable market we outlined in our recent earnings call, this launch accelerates momentum in our dental business, one of our most significant growth initiatives, and reinforces its role as a key driver of long-term shareholder value. We are excited about these accomplishments and the substantial business opportunities they generate."

Powered by the NextDent 300 MultiJet 3D printer and specialized NextDent Jet Base and Teeth materials, the solution enables dental labs to produce durable, aesthetically superior, one-piece dentures far faster and more cost-effectively than traditional analog methods. This delivers both outstanding patient outcomes and strong return on investment for labs and clinicians.

This regulatory achievement further solidifies 3D Systems' leadership position in digital dentistry and supports the Company's broader strategic initiatives to expand in high-value healthcare applications.

About 3D Systems For nearly 40 years, Chuck Hull's curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future. More information on the Company is available at www.3dsystems.com.

Forward-Looking Statements Certain statements in this press release are forward-looking, including statements regarding the timing of product launches, regulatory timelines, market opportunities, and the expected impact on growth and shareholder value. Actual results may differ materially due to risks and uncertainties detailed in the Company's SEC filings. 3D Systems undertakes no obligation to update any forward-looking statements.

Investor Contact: [email protected]

Media Contact: [email protected]