3D Systems Receives FDA Clearance for NextDent® Base

Today, 3D Systems (NYSE:DDD) announced the Food and Drug Administration (FDA) has provided 510(k) clearance for its NextDent Base material that is intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures. This material is approved by Health Canada and also received CE marking 1639. NextDent Base is the third generation of the company’s denture base material for 3D printing and has excellent mechanical properties including high break resistance, and accurate and repeatable printability. NextDent Base is truly comparable to conventional denture materials and provides patients with long-lasting, impact-resistant dentures. Additionally, the material is available in four colors to match the most popular gingiva shades for improved aesthetics. Using NextDent Base as part of 3D Systems’ digital dental workflow is helping drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.

NextDent Base is already receiving positive feedback in the market. Steven Campbell, RDT FCGDent, with Nexus Dental Laboratory (Harrogate, United Kingdom) has been running trial tests with the material and stated, “This new material is truly amazing! No support bar across the heels, lovely delicate supports which are easy to remove, and the fit of the teeth to denture and denture to bar show just how stable this is. We have just started trials with it, but already I can see the strength of this is going to make it an incredible material to keep an eye on. We are so confident in the strength we see on early prints that we are going to run some test partials with it.”

Additionally, Dr. Kunal Lal, DDS, MS, Board Certified Prosthodontist, at LAL Dental (New York, New York) said, “I really enjoyed testing the NextDent Base material. It is pink, flexible in thinner sections, and can be used for same-day interim RPD fabrication. Some of the other properties worth noting are minimal mixing, cleaning of residual material on the surface is easier, and improved strength.”

The adoption of 3D printing to produce prosthodontics continues to accelerate, yet there is still significant opportunity. According to 360 Research Reports, 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 2028. The use of digital workflows such as 3D Systems’ digital dentistry solution comprising its NextDent Base material, along with its NextDent 3D printing technology with a trusted connection with industry-leading software packages, results in a complete workflow including post-processing to ensure the best possible product. With 3D Systems’ NextDent solution, dental laboratories and clinics are now able to produce dental devices at dramatically increased speed while reducing material waste and capital equipment expenditure as well as reliance upon milling centers. Benefits also extend to the patient by reducing the time it takes to produce prosthodontics, as well as the number of required office visits.

“Our goal is to ensure we are addressing our customers’ needs with our solutions, and this is yet another step in achieving that goal,” said Chuck Stapleton, vice president and general manager, dental, 3D Systems. “With the clearance of NextDent Base, we continue to add to our portfolio of dental 3D printing materials that are enabling dental laboratories and clinics to address a wide range of applications. These offerings are helping our customers accelerate the adoption of additive manufacturing as part of their workflows and drive new levels of speed, productivity, efficiency, and precision while also providing opportunities to improve the patient experience.”

NextDent Base is the latest addition to 3D Systems’ portfolio of 30 unique NextDent resins – the largest number available from any dental 3D printing material supplier. The material is available in four colors to match a variety of aesthetics and is available for immediate ordering.

NextDent 3D printing materials for medical devices are biocompatible and CE-certified in accordance with Medical Device Directive 93/42/EEC, listed at the FDA, and registered in various other countries. The complete NextDent portfolio – for both medical and non-medical devices – is suitable for a wide range of 3D-printed dental applications. For more information, please visit the company’s website.

Forward-Looking StatementsCertain 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 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, 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 www.3dsystems.com.