3D Systems Secures Class IIa EU MDR Certification for NextDent® Jetted Denture Solution, Enabling Full European Commercial Launch Two Months Ahead of Schedule

3D Systems (NYSE: DDD) received Class IIa EU MDR certification for the NextDent Jet Base and Jet Teeth materials plus the NextDent 300 MultiJet printer, enabling full commercial launch across the EU on May 4, 2026, two months ahead of the prior target.

Rhea-AI Summary

3D Systems (NYSE: DDD) received Class IIa EU MDR certification for the NextDent Jet Base and Jet Teeth materials plus the NextDent 300 MultiJet printer, enabling full commercial launch across the EU on May 4, 2026, two months ahead of the prior target.

The certification expands the addressable market to over 60 million edentulous patients across the US and EU and enables a complete monolithic, multi-material jetted denture workflow for dental labs and clinics.

Positive

• Class IIa EU MDR certification secured for NextDent jetted denture solution
• European commercial availability begins May 4, 2026
• Addresses >60 million edentulous patients across US and EU
• Industry-first monolithic, multi-material jetted denture workflow
• Early U.S. launch feedback shows strong patient satisfaction

Negative

• None.

Argus Apr 28 session

-0.45% close to close Open Argus

Details

News Market Reaction – DDD

In the Apr 28 session, DDD declined 0.45%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details Class IIa EU MDR certification for 3D Systems’ NextDent Jetted Denture Sol...

Analysis

This announcement details Class IIa EU MDR certification for 3D Systems’ NextDent Jetted Denture Solution, enabling an EU launch on May 4, 2026 and targeting over 60 million edentulous patients. It builds on the full-scope EU MDR certification from Mar 17, 2026 and complements prior guidance of $91–$94M in Q1 2026 revenue. Investors may monitor how quickly European dental labs adopt this workflow and how it contributes to recurring premium materials revenue alongside recent cost savings of about $55M.

Key Figures

Addressable edentulous patients: over 60 million patients Q4 2025 revenue: $106.3M 2025 revenue: $386.9M +5 more

Addressable edentulous patients

over 60 million patients

US and EU denture market for NextDent platform

Q4 2025 revenue

$106.3M

Fourth quarter 2025 results

2025 revenue

$386.9M

Full-year 2025 revenue vs 2024

2024 revenue

$440.1M

Full-year 2024 revenue comparator

Cost savings

$55M

Annualized cost savings delivered in 2025

2025 GAAP net income

$29.9M

Full-year 2025 GAAP net income

Q1 2026 revenue guidance

$91–$94M

Guidance provided with Q4/FY 2025 results

U.S. replacement market

$600M

Estimated addressable U.S. denture replacement market by 2029

Historical Context

5 past events · Latest: Apr 13

5 events

1. Apr 13

   Product platform launch

   24h Move

   +2.6%

   Introduced SLA 825 Dual system and AddiTrak factory software to boost throughput.

2. Mar 25

   Regulatory certification

   24h Move

   +1.9%

   Received full-scope EU MDR certification enabling phased rollout of dental products.

3. Mar 23

   Management change

   24h Move

   +5.7%

   Appointed Phyllis Nordstrom as permanent CFO and CAO, reinforcing leadership team.

4. Mar 09

   Earnings results

   24h Move

   +28.1%

   Reported Q4 and FY 2025 results with cost savings and positive GAAP net income.

5. Mar 02

   Earnings date notice

   24h Move

   -0.5%

   Announced timing and access details for Q4 and full-year 2025 earnings call.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

class iia, european union medical device regulation, mdr 2017/745, multijet 3d printer

4 terms

class iia regulatory

"have received Class IIa certification under the European Union Medical Device"

A Class IIa designation is a regulatory category for medical devices that signals a low-to-medium level of risk to patients and users. It determines the amount of testing, documentation and outside review a device needs before it can be sold—think of it as a safety rating that dictates how strict the approval process will be. For investors, that rating matters because it affects development costs, approval time, ongoing compliance obligations and potential liability, all of which influence a product’s timeline and profitability.

european union medical device regulation regulatory

"certification under the European Union Medical Device Regulation (MDR 2017/745)."

A set of European rules that governs how medical devices are designed, tested, labeled and sold in the European Union; think of it as building codes for medical products that set safety and performance standards and require official review before devices reach patients. Investors care because these rules determine which products can be sold, how long approvals take, and how much companies must spend to comply—factors that affect revenue, timelines and risk.

mdr 2017/745 regulatory

"European Union Medical Device Regulation (MDR 2017/745). This regulatory milestone"

A European regulation that sets the safety, testing and approval rules for medical devices sold in the EU. For investors, it matters because it raises the bar for product testing, documentation and ongoing oversight—like stricter building codes for homes—so companies may face higher costs, longer approval times, or reduced market access if they cannot meet the requirements.

multijet 3d printer technical

"NextDent 300 MultiJet 3D printer, have received Class IIa certification"

A multijet 3D printer is an additive manufacturing machine that builds objects by spraying many tiny droplets of material layer by layer, often using multiple print heads to deposit different resins or colors in the same part. For investors, it matters because this technology can speed up prototyping, reduce tooling costs, and produce complex, customized parts at scale—factors that can change a manufacturer’s cost structure, product agility, and competitive edge.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• European commercial availability begins May 4, 2026, two months ahead of the previously targeted summer launch
• Certification expands the addressable market for the Company’s flagship dental printing platform to over 60 million edentulous patients across the US and EU, representing a multi-billion dollar denture market
• Early feedback from the U.S. market launch highlights strong patient satisfaction with denture aesthetics, comfort, and performance using NextDent 300 technology
  

ROCK HILL, S.C., April 28, 2026 (GLOBE NEWSWIRE) -- 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: www.3dsystems.com/dental-jetted-dentures

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. More information is available at www.3dsystems.com.

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.

Investor Contact: investor.relations@3dsystems.com

Media Contact: press@3dsystems.com

FAQ

When will 3D Systems (DDD) make the NextDent Jetted Denture Solution commercially available in EU markets?

The NextDent Jetted Denture Solution will be commercially available in the EU on May 4, 2026. According to the company, distribution will occur through 3D Systems and its authorized partners across EU markets, enabling immediate customer access to the full workflow.

What regulatory milestone did 3D Systems (DDD) achieve for NextDent jetted dentures under EU rules?

3D Systems received Class IIa certification under EU MDR (2017/745) for NextDent Jet Base, Jet Teeth, and the NextDent 300 printer. According to the company, this certification permits full commercialization across EU member states for moderate-risk dental devices.

How large is the addressable market cited by 3D Systems (DDD) after EU certification?

The certification expands the addressable market to over 60 million edentulous patients across the US and EU. According to the company, this segment represents a multi-billion-dollar denture market for its platform and premium materials.

What product capabilities does the NextDent 300 MultiJet solution offer for dental labs and clinics?

The NextDent 300 enables a monolithic, multi-material jetted denture printed in a single job, fully cured and ready for finishing. According to the company, this workflow aims to improve accuracy, consistency, and production speed versus traditional analog methods.

Will existing European customers receive certified materials and support from 3D Systems (DDD)?

Yes. According to the company, European customers can access a complete regulatory-compliant workflow, including certified materials, hardware, software, and application expertise from 3D Systems and authorized distributors starting May 4, 2026.