3D Systems Gains FDA Approval for Multi-Material 3D Printed Dentures

US-based 3D printer manufacturer 3D Systems has achieved a significant milestone with the FDA’s 510(k) clearance for its multi-material, 3D printed dentures. As reported by 3DPrintingIndustry.com, this development marks the company’s “first-to-market” product in the dental sector, a solution that integrates 3D Systems’ NextDent Jet Denture Teeth and Base materials into a single, monolithic denture.

Launched in February 2024, these one-piece dentures boast improved break resistance and enhanced aesthetics. The clearance from the Food and Drug Administration (FDA) confirms that the product is safe and effective, enabling its commercial release. This clearance aligns with 3D Systems’ broader goal of expanding its digital dentistry portfolio, a sector projected to exceed $2 billion by 2028.

Breakthrough Technology with NextDent Materials and MultiJet Printing

A key differentiator of 3D Systems’ new denture solution lies in its innovative combination of materials. The company’s proprietary MultiJet Printing (MJP) technology plays a central role, seamlessly merging its NextDent Jet Denture Teeth and Base materials into a life-like denture in a single print job.

The denture teeth are formulated to reflect both the rigidity and aesthetics of natural teeth, while the base is optimized for impact absorption, enhancing break resistance. This, in turn, helps accelerate production capabilities for dental laboratories. According to Neil McCaffrey, 3D Systems’ new head of Dental, this solution “reflects [the company’s] commitment to the dental laboratory by offering a complete system that enhances automation and profitability within a traditionally labor-intensive workflow.”

The automation embedded in the jetted denture solution allows for high-volume production, reducing manual input and increasing throughput. This is a leap forward for dental labs seeking efficiency and reliability in their workflow.

Positive Industry Reception

Industry leaders are already looking to implement the newly FDA-cleared dentures into their production lines. Restorative dental device manufacturer Glidewell previewed the solution before its official clearance, and the company is now working to integrate it into its production processes. Glidewell CEO Stephenie Goddard praised the collaboration, stating, “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 collaboration highlights how 3D Systems’ technology is transforming not just dental manufacturing but also the patient experience by making dentures more durable and aesthetically pleasing.

Competitive Landscape in the 3D Printed Denture Market

While 3D Systems’ jetted denture solution is revolutionary, it is not without competition. Stratasys, another player in the 3D printing space, offers the J5 DentaJet 3D printer, which allows for batch production of aesthetic, monolithic, multicolor dental appliances. However, it lacks multi-material capabilities, positioning 3D Systems’ offering as a distinctive innovation in the dental market.

McCaffrey emphasizes that the multi-material jetted dentures provide a substantial advantage for patients and dental professionals alike: “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.”

The Growing Role of 3D Printing in Dental Prosthetics

The rise of 3D printing in dental prosthetics is undeniable. According to 3DPrintingIndustry.com, the global market for 3D printed dentures exceeded $1 billion in 2021, and it is expected to grow past $2 billion by 2028. This rapid expansion underscores the increasing reliance on 3D printing technologies to streamline dental processes and improve patient outcomes.

This trend is further evidenced by other FDA clearances in the field. For example, Formlabs Dental recently gained 510(k) clearance for its 3D printable Premium Teeth Resin, which allows dental professionals to 3D print temporary crowns, inlays, veneers, and bridges. Meanwhile, Desktop Health has released a new formulation of its Flexcera resin, Flexcera Base Ultra+, which boasts enhanced strength and resistance to deformation.

The Future of 3D Printed Dentures

The FDA’s approval of 3D Systems’ denture solution represents a major leap forward in dental manufacturing, enhancing the efficiency, durability, and aesthetics of dentures. With increasing digital integration in dental labs, the new technology sets a high bar for future advancements in this space. As 3D Systems continues to refine its solutions, the dental industry could soon see a shift towards more automated, precise, and patient-specific prosthetics.

In conclusion, 3D Systems’ FDA-cleared, multi-material dentures signify a pivotal moment in the evolution of digital dentistry. McCaffrey’s statement sums up the broader implications: “It’s a win-win-win for laboratories, dentists, and patients.” As the market for 3D printed dentures expands, innovations like these will play a crucial role in shaping the future of dental care.