US-based 3D printer manufacturer 3D Systems has received 510(k) clearance from the Food and Drug Administration (FDA) for its multi-material, 3D printed denture offering.
Launched last February, the jetted, monolithic (one-piece) dentures are being billed as a “first-to-market” product that offers unparalleled break resistance and optimal aesthetics.
The novelty of this offering lies in the integration of 3D Systems’ NextDent Jet Denture Teeth and NextDent Jet Denture Base materials into a single denture solution. It also leverages the company’s MultiJet Printing (MJP) technology, software and services.
The new FDA 510(k) clearance confirms that the solution is safe and effective, allowing it to be sold on the commercial market. Achieving this certification reportedly marks a significant milestone in 3D Systems’ strategic initiative to expand its digital dentistry solution portfolio addressing tooth alignment, protection, repair, and replacement. The denture market is expected to exceed $2 billion by 2028.
Restorative dental device manufacturer Glidewell had previously received a preview of the solution. It is now working to implement the 3D printed denture capabilities into its production workflow. By adopting the newly FDA-cleared offering, 3D System claims that dental laboratories can more efficiently deliver dentures for an improved patient experience.
“We’ve worked with 3D Systems for many years, and using their digital dentistry solutions has helped us achieve tremendous success for our patients,” commented Glidewell CEO Stephenie Goddard.
“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.”
Upper and lower 3D printed dentures from 3D Systems. Photo via 3D Systems.
FDA approval for multi-material 3D printer denture solution
In an interview with 3D Printing Industry last year Chuck Stapleton, former Vice President and General Manager for Dental at 3D Systems, outlined the company’s vision for scaling 3D printed dental products into mainstream production. This included a focus on exploiting “previously underutilized technologies such as jetting” to unlock new applications.
According to Neil McCaffrey, who superseded Stapleton in July as the new head of Dental, the replacement of teeth using jetting-based technology remains a key pillar of the company’s dental strategy.
“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,” he added.
Key to 3D Systems’ 3D printed denture solution is its NextDent materials, which can be combined into a life-like, monolithic denture in a single print job.
3D Systems acquired NextDent back in 2017, in a move that propelled the company firmly into the dental sector. According to 3D Systems, NextDent Jet Denture Teeth is uniquely formulated to accurately reflect tooth rigidity and aesthetics. NextDent Jet Denture Base, on the other hand, is optimized to absorb impact, resulting in high break resistance.
Manufacturing on Demand
The monolithic 3D printed denture technology is also reportedly optimized for high-volume production. 3D Systems claims that its automated jetting solution significantly accelerates denture 3D printing capabilities, increases throughput, and minimizes manual input.
“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,” stated McCaffrey.
While it is not the only denture 3D printing solution, the ability to produce dentures with true multi-material properties differentiates 3D Systems’ offering in the dental market. For instance, Stratasys‘ J5 DentaJet 3D printer offers “batch production of highly aesthetic, monolithic, multicolor dental appliances on a single mixed part, high-capacity tray,” but lacks multi-material capabilities.
“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,” added McCaffrey. “It’s a win-win-win for laboratories, dentists, and patients.”
3D printed jetted, multi-material, and monolithic dentures from 3D Systems. Photo via 3D Systems.
3D printing enhances the growing dental market
3D printing is playing a vital role in the production of dental prosthetics, and it is seeing accelerated use in this growing market. 360 Market Updates has estimated the global 3D printed dentures market size to be over $1 billion in 2021. This is forecast to exceed $2 billion by 2028.
Earlier this year, Formlabs Dental, the dental business unit of Resin 3D printer manufacturer Formlabs, received 510(k) FDA clearance for its 3D printable Premium Teeth Resin.
Dental professionals in the US can now use the material to 3D print temporary single units of crowns, inlays, onlays, veneers, and up to seven-unit temporary bridges. Compatible with Form 3B+, Form 3BL, and Form 4B 3D printers, the resin is also cleared for use in the EU, UK, Switzerland, and Canada. It allows dental parts to be customized for each patient’s intraoral anatomy, allowing it to cater to diverse patient needs.
Elsewhere, Desktop Health, the healthcare business unit of Massachusetts-based industrial 3D printer manufacturer Desktop Metal (DM), released a new formulation of its Flexcera resin for 3D printing gingiva.
The 3D printable light-curable resin, called Flexcera Base Ultra+, is reportedly 50% stronger than its predecessors. It is also said to offer 70% greater resistance to deformation than ISO standards. Desktop Health’s new formulation is a nano-ceramic composite resin that enables the production of thinner designs of 2.5 mm wall thickness and 1 mm socket thickness.
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Author: Alex Tyrer-Jones
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