Desktop Health Receives FDA Clearance for Flexcera for Next Generation 3D Printed Dentures
Proprietary Resin Technology for Dental Prosthetics Delivers Superior Strength, Aesthetics and Function for Patients.
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 with three times the toughness of competitor denture material and lifelike tooth translucency. (Photo: Business Wire)
- Developed, tested, and selected from more than 200 formulations
- Unique long-chain chemistry formulated and optimized for 3D printing
- Pioneers a same-day digital denture solution with three times the toughness of competitor denture material and lifelike tooth translucency
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.
“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.
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)
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.
For the first time in dental prosthetics, Flexcera offers:
- High fracture resistance, three times more resistant to fracture than select competitive resins;
- Moisture resistance to prevent staining or discoloration, two times more resistant than a leading competitive formulation; and
- An overall natural aesthetic that offers lifelike tooth translucency and a natural-looking smile.
“Desktop Health has changed my approach to personalized dentistry,” said Dr. Ryan Dunlop, DMD of Full Arch Masters, one of the leading experts 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 deliver beautiful, high-quality and same-day dental prosthetics in record time, customized to the patient, while they are in the chair.”
Desktop Health will present the details of this new technology to dental professionals for the first time at the LAB DAY Online Spring meeting on May 12 and May 14, 2021. More Information about the LAB DAY program is available at: https://lmtmag.com/shows/lab-day-online-spring-2021.
Flexcera is expected to launch commercially in the U.S. and Canada by the end of June. Healthcare providers who wish to stay updated on product availability, or place a pre-order, can sign up at www.flexcera.com.
www.desktopmetal.com
