Desktop Health Receives FDA Clearance for Flexcera for Next Generation 3D Printed Dentures
Desktop Health, recently launched by Desktop Metal, Inc. (NYSE: DM) and committed to developing 3D printing and biofabrication solutions for personalized medicine, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of FlexceraTM Base, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. Flexcera Base along with the new FlexceraTM Smile are Desktop Health’s first formulated and optimized digital dental solutions.
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Desktop Health has received FDA 510(k) clearance of Flexcera Base, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. The introduction of Flexcera Base and Flexcera Smile marks the inception of a remarkable new era in dentistry, combining advanced science with 3D printing technology to deliver superior strength, aesthetics, and function for patients. (Photo: Business Wire)
“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 & CEO of Desktop Health. “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. We are pleased to bring this innovative product to market as it represents our commitment to meet the needs of dental professionals and their patients.”
The need for dental prosthetics is on the rise, with the global dentures market estimated to reach $3.8 billion USD by 20271. In the U.S. alone, more than 36 million are edentulous, meaning they have no natural teeth, with 90 percent of those wearing dentures2. According to the American Association of Oral and Maxillofacial Surgeons, 69 percent of adults ages 35 to 44 have lost at least one permanent tooth to an accident, gum disease, a failed root canal or tooth decay3.
The Science of Printing Teeth
Flexcera was developed with the strength of ceramic coupled with long chain chemistry to ensure optimal denture properties. When used exclusively with EnvisionTEC 3D printers, dental providers can print up to eight customized Flexcera dentures in less than two hours, delivering on the promise of same-day, high-quality dental prosthetics.