3D Systems receives FDA approval for monolithically manufactured multi-material tooth replacement solution

3D Systems announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for its multi-material, one-piece dental prosthesis solution. This first-to-market offering, which includes two uniquely engineered materials – NextDent Jet Denture Teeth and NextDent Jet Denture Base – as well as 3D Systems’ jetting technology, software and services, enables the fabrication of durable, long-lasting and aesthetically pleasing dentures.

3D Systems’ partnership with Glidewell, one of the world’s largest manufacturers of dental restorations, has led to the implementation of this solution.

“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.”

This innovation stands out from previous systems due to its ability to produce genuine multi-material dental prostheses. In addition to their high fracture resistance, the prostheses offer improved aesthetic properties.

“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.”

With the increased use of digital imaging and personalised treatment planning in dental practices worldwide, the digitalisation of denture fabrication is setting new standards. 3D Systems enables dental laboratories and clinics to optimise their workflows, reduce material consumption and lower investment costs. Patients benefit from shorter waiting times, fewer visits to the dentist and more durable prostheses that are both functional and comfortable.

With a market volume of over one billion US dollars in 2021 and a forecast of more than two billion by 2028, the growth potential for 3D-printed dentures is clear.