3D Systems Garners FDA Clearance for Multi-material, Monolithic Jetted Denture Solution

3D printing pioneer 3D Systems today announced the Food and Drug Administration (FDA) has provided 510(k) clearance for its multi-material, monolithic (one-piece) jetted denture solution, providing the ability for dental laboratories to more efficiently deliver dentures and resulting in an enhanced patient experience.

This first-to-market offering comprises 2 uniquely developed materials — NextDent® Jet Denture Teeth and NextDent® Jet Denture Base. The materials, combined with 3D Systems’ jetting technology, software, and services are designed to enable the production of durable, long-wear, esthetic dentures.

Glidewell, one of the world’s largest dental laboratories and producers of restorative dental devices—through its partnership with the 3D company—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,” Stephenie Goddard, CEO, Glidewell, says in today’s press release. “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.”

3D printing capabilities continue to grow in the dental industry, with big strides in particular coming in the production of prosthodontics.

Related reading: 3D Printing: Bigger & Better

“With the FDA clearance of our jetted denture solution, 3D Systems continues to expand our market-leading digital dentistry solution portfolio,” adds 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 1-piece denture with hard, wear-resistant, esthetically 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.”

As 3D printing continues to play a significant role in the production of prosthodontics, 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 2028.¹ 3D Systems’ digital dentistry solutions, including its multi-material, monolithic jetted denture solution, help 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.

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.

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