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

3D Systems 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.

“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 2028. 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.

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