3D Systems Receives FDA Clearance for First-to-Market Multi-material, Monolithic Jetted Denture Solution

Rhea-AI Summary

3D Systems (NYSE:DDD) has received FDA 510(k) clearance for its innovative multi-material, monolithic jetted denture solution. This first-to-market offering combines NextDent® Jet Denture Teeth and NextDent® Jet Denture Base materials with 3D Systems' jetting technology, software, and services. The solution enables the production of durable, long-wear, and aesthetically pleasing dentures in a single print session.

Glidewell, a major dental device producer, is implementing this solution into its production workflow. The FDA clearance represents a significant milestone in 3D Systems' strategic initiative to expand its digital dentistry solution portfolio. This new denture product family is expected to tap into a market estimated to exceed $2 billion by 2028, significantly expanding the company's addressable dental market.

Positive

• FDA 510(k) clearance received for multi-material, monolithic jetted denture solution
• First-to-market offering combining unique materials and 3D Systems' technology
• Partnership with Glidewell, one of the world's largest dental laboratories
• Expansion of addressable dental market, with denture demand estimated to exceed $2 billion by 2028
• Solution enables more efficient denture production for dental laboratories

Negative

• None.

• Unique multi-material, single-piece dentures offer unparalleled combination of distinctive break resistance and outstanding aesthetics for enhanced patient experience
  
• Solution being implemented by Glidewell, one of the world’s largest dental laboratories
• FDA clearance represents another important milestone in Company’s strategic initiative to expand its market-leading digital dentistry solution portfolio addressing alignment, protection, repair, replacement of teeth
• New denture product family significantly expands company’s addressable dental market, with denture demand estimated to exceed $2 billion by 2028

ROCK HILL, S.C., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Today, 3D Systems (NYSE:DDD) announced the Food and Drug Administration (FDA) has provided 510(k) clearance for its multi-material, monolithic (one-piece) jetted denture solution. This first-to-market offering comprising two uniquely developed materials — NextDent^® Jet Denture Teeth and NextDent^® Jet Denture Base — as well as 3D Systems’ jetting technology, software and services, enables the production of durable, long-wear, aesthetically beautiful dentures. As a result of implementing the Company’s FDA-cleared jetted denture solution, dental laboratories can more efficiently deliver dentures, resulting in an enhanced patient experience.

Glidewell, one of the world’s largest producers of restorative dental devices, through its partnership with 3D Systems, received a preview of this solution and is now in the process of implementing it into its production workflow. “We take great pride in pioneering the use of new technologies to continually enhance our products and services,” said Stephenie Goddard, CEO, Glidewell. “We’ve worked with 3D Systems for many years, and using their digital dentistry solutions has helped us achieve tremendous success for our patients. As the first dental lab to have access to 3D Systems’ new multi-material, monolithic jetted denture workflow, we are looking forward to implementing a significantly better denture solution for our customers and their patients.”

“With the FDA clearance of our jetted denture solution, 3D Systems continues to expand our market-leading digital dentistry solution portfolio,” said Neil McCaffrey, vice president & general manager, dental, 3D Systems. “Replacement of teeth is a key pillar of our dental strategy, which is directly supported by this latest innovation. Our jetted denture solution reflects our commitment to the dental laboratory by offering a complete system that enhances automation and profitability within a traditionally labor-intensive workflow. This solution integrates innovations in hardware, software, materials, and process expertise, delivering in a single print session a one-piece denture with hard, wear-resistant, aesthetically beautiful teeth, in combination with tough, durable gingiva properties. Unlike other systems, our printer can produce a denture with true multi-material properties—not just color. With the growing use of digital imaging and personalized treatment planning in dental clinics worldwide, digitizing denture fabrication sets a new standard for creating robust, precise dental prosthetics that patients can truly see and feel. It's a win-win-win for laboratories, dentists, and patients.”

3D printing continues to play a significant role in the production of prosthodontics and its use is accelerating, driven by the benefits it delivers for both manufacturers and patients. According to 360 Market Updates, the global 3D Printed Dentures market size was estimated to be more than $1 billion in 2021 and is forecast to reach more than $2 billion by 2028¹. 3D Systems’ digital dentistry solutions, including its multi-material, monolithic jetted denture solution, enable dental labs and clinics to streamline dental device production, while reducing material waste and lowering capital investment requirements. Patients also benefit from faster turnaround times for prosthetics, fewer dental appointments, and enhanced device durability and comfort.

For more information on 3D Systems’ jetted denture solution, please visit the Company’s website.

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. 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 revise any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise, except as required by law.

About 3D Systems
More than 35 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction — empowering our customers to create products and business models never before possible. Thanks to our unique offering of hardware, software, materials, and services, each application-specific solution is powered by the expertise of our application engineers who collaborate with customers to transform how they deliver their products and services. 3D Systems’ solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods. More information on the company is available at https://www.3dsystems.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fdc3f56e-aae2-4ae0-8908-21d185db789e

Investor Contact:	investor.relations@3dsystems.com
Media Contact:	press@3dsystems.com

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¹ 360 Market Updates, “Global 3D Printed Dentures Market Research Report 2022 (Status and Outlook)”, June 2022.

FAQ

What FDA clearance did 3D Systems (DDD) receive for its dental solution?

3D Systems received FDA 510(k) clearance for its multi-material, monolithic (one-piece) jetted denture solution, which combines NextDent® Jet Denture Teeth and NextDent® Jet Denture Base materials with 3D Systems' jetting technology, software, and services.

How does 3D Systems' (DDD) new denture solution benefit dental laboratories?

The new denture solution enables dental laboratories to produce durable, long-wear, and aesthetically pleasing dentures more efficiently in a single print session, resulting in an enhanced patient experience and potentially improved profitability.

What is the estimated market size for 3D printed dentures by 2028?

According to the press release, the global 3D Printed Dentures market is forecast to reach more than $2 billion by 2028, representing a significant opportunity for 3D Systems (DDD) and its new denture solution.

Which major dental laboratory is implementing 3D Systems' (DDD) new denture solution?

Glidewell, one of the world's largest producers of restorative dental devices, is in the process of implementing 3D Systems' FDA-cleared jetted denture solution into its production workflow.