ROCK HILL, South Carolina, November 6, 2019 – Today, 3D Systems (NYSE:DDD) announced that its new biocompatible denture material, NextDent® Denture 3D+, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The combination of this new dental 3D printing material, NextDent 5100 dental 3D printer, and industry-leading intra-oral scanning and dental software solutions yields an end-to-end digital dentistry solution. As a result, customers can expect more precise, predictable results than through analog techniques - enabling more efficient, cost-effective creation of dentures for patients.
Producing a denture using NextDent Denture 3D+ for the base, and NextDent C&B MFH for the teeth on the NextDent 5100 results in a final denture that is 90% less expensive to produce in 75% less time than dentures created using analog methods. The digital solution improves the patient experience as well, providing a properly fitting device with fewer required office visits.
“With 3D Systems’ Digital Denture Workflow, 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,” said Rik Jacobs, vice president, general manager, dental, 3D Systems. “FDA clearance of NextDent Denture 3D+ is the last piece that creates a trusted end-to-end workflow – giving prosthodontists a competitive advantage while improving the patient experience.”
NextDent Denture 3D+ material possesses excellent mechanical properties (in accordance with ISO Denture Base Standards) and is capable of producing dentures rivaling conventional denture base materials. 3D Systems offers the largest available color palette for a denture base material, which enables dental labs and clinics to deliver a final product that most closely matches a patient’s gums for a natural looking aesthetic. This material joins the company’s portfolio of 30 unique NextDent resins – the largest number available from any dental 3D printing material supplier. NextDent 3D printing materials for medical devices are biocompatible and CE certified (CE certification is pending for NextDent Denture 3D+) 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 applications.
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 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.
About 3D Systems
More than 30 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading AM solutions company, it empowers manufacturers to create products and business models never before possible through transformed workflows. This is achieved with the Company’s best-of-breed digital manufacturing ecosystem - comprised of plastic and metal 3D printers, print materials, on-demand manufacturing services and a portfolio of end-to-end manufacturing software. Each solution is powered by the expertise of the company’s application engineers who collaborate with customers to transform manufacturing environments. 3D Systems’ solutions address a variety of advanced applications for prototyping through production in markets such as aerospace, automotive, medical, dental and consumer goods. More information on the company is available at www.3dsystems.com.