Desktop Metal’s Health business receives FDA clearance for Flexcera resins for 3D printed dentures
Desktop Health, the recently launched health business belonging to metal 3D printer manufacturer Desktop Metal, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its proprietary Flexcera Base resin used in the 3D printing of dental prosthetics.
Developed, tested and chosen from over 200 formulations, Flexcera Base joins Flexcera Smile as Desktop Health’s first formulated and optimized dental resins.
“Three years ago, we set out to create a product that addressed the limitations of current 3D printed dental prosthetics – brittleness and poor aesthetics,” said Michael Jafar, President and CEO of Desktop Metal.
“The introduction of Flexcera marks the inception of a remarkable new era in dentistry, combining advanced Flexcera science with 3D printing technology to deliver superior strength, aesthetics, and function for patients.”
3D printing dental prosthetics
According to recent reports, the global dentures market is estimated to reach $3.8 billion by 2027. The dental applications of 3D printing are also continuing to grow with the development of new resins and dental-specific 3D printers.
One firm active in this sector is 3D printer manufacturer Nexa3D, which launched its latest resin-based dental 3D printer in April, the NXD200. Prior to the launch, the firm also partnered with dental materials developer KeyStone Industries in order to offer a full suite of specialist 3D printing resins with the NXD200.
Having stepped up its dental offering over the past few years, fellow 3D printer manufacturer Formlabs recently added two new materials to its dental portfolio for the creation of permanent crowns and a starter pack for users to create tailored resins for dental models.
In March, 3D printer manufacturer Stratasys launched its latest multi-material Polyjet 3D printer designed specifically for dental applications. Capable of printing up to five different biocompatible resins at once, the J5 DentaJet enables medical professionals to 3D print mixed trays of high-precision dental parts in a single job.
Elsewhere, orthodontics firm Candid has partnered with 3D printer OEM Carbon to produce 3D printed customized clear dental aligner models, and 3D printable photopolymer resin manufacturer Graphy launched its dental 3D printing material brand, Tera Harz, in a bid to overcome the limitations posed by other 3D printable materials currently used within the dental sector.
Desktop Health’s Flexcera resins
Engineered with long chain chemistry formulated and optimized for 3D printing, the Flexcera resins are developed with the strength of ceramic materials in order to ensure optimal denture properties. The resins are designed exclusively for use with EnvisionTEC 3D printers, which Desktop Metal acquired at the beginning of the year for $300 million.
This machine and resin combination reportedly enables users to print up to eight customized dentures in less than two hours, allowing dental providers to offer same-day, high quality dental prosthetics to their customers.
According to Desktop Health, dentures printed with its Flexcera resins are three times more resistant to fractures than select competitive resins, and are also moisture resistant in order to prevent staining and discoloration. The resins also give dentures an “overall natural aesthetic” that offers realistic tooth translucency.
“Desktop Health has changed my approach to personalized dentistry,” said Dr. Ryan Dunlop, DMD of Full Arch Masters, a leading expert in dental implants and digital dentistry. “The Flexcera resin delivers on the four cornerstones of why 3D printing works so well: strength, high aesthetics, accuracy, and speed.
“With Flexcera, I am now able to offer beautiful, high-quality and same-day dental prosthetics in record time, cutomized to the patient, while they are in the chair.”
The Flexcera range is made up of the newly FDA-cleared Flexcera Base, designed for the fabrication of premium denture bases, and Flexcera Smile, engineered for the production of lifelike denture teeth. Both are formulated for use exclusively with EnvisionTEC 3D printers.
Desktop Health is currently presenting the details of its Flexcera resin technology to dental professionals at the LAB DAY Online Spring Meeting, spanning 12-14th May. Following this, Flexcera is expected to launch commercially in the US and Canada by the end of June.