Tested And Confirmed
3D printers continue to become more and more common in healthcare areas. Before and during the pandemic, 3D printing was and continues to be used a lot in the healthcare field. In fact, we seem to be a little unfair to 3D printing by saying that it was used, because they not only add strength to the health sector, but also save lives with their integration into respirators.
With the latest developments, 3D printers have broken new ground. 3D printing resins for dentures have been approved by the FDA. Desktop Health announced that it has received FDA 510(k) clearance for Flexcera Base, a proprietary resin for use in high-end dental prosthetics in 3D printing. It has been reported to improve existing 3D-printed prostheses due to improved fracture resistance and appearance. “Three years ago, we began creating a product that addresses the limitations, fragility and aesthetics of existing 3D-printed dental prostheses,” said Michael Jafar, President and CEO of Desktop Health. “The launch of Flexcera marks the beginning of a remarkable new era in dentistry that combines advanced Flexcera science with 3D printing technology to provide superior strength, aesthetics and function for patients.”
Desktop Health's Flexcera consists of proprietary resins for the manufacture of functional prosthetics with ceramic-like strength. The Flexcera Smile is an FDA Class 1 medical device for the manufacture of realistic denture teeth and the Flexcera Base is an FDA approved Class 2 medical device for the manufacture of premium denture bases. Both are specially formulated for use with EnvisionTEC 3D printers. According to Fortune Business Insights, the need for dental prosthetics is growing and the global prosthetic market is predicted to reach $3.8 billion by 2027. According to a study cited by the American College of Prosthodontics Desktop Health, more than 36 million people in the United States alone do not have natural teeth, and 90% of them wear dentures. The American Society for Oral and Maxillofacial Surgery reported that 69% of adults aged 35-44 have lost at least one permanent tooth due to an accident, gum disease, a failed root canal or tooth decay. Flexcera combines the strength of ceramic with long-chain chemistry to ensure optimum prosthetic properties. When used with EnvisionTEC 3D printers, the resin allows dentists to print up to eight custom Flexcera dentures in less than two hours. Desktop Health said in an announcement that its dentures are three times more resistant to breakage than certain competitive resins and are twice as resistant to moisture staining or discoloration than a leading competitive formula. The company added that its dental products offer lifelike tooth transparency and a natural-looking smile. Flexcera is expected to be commercially available in the United States and Canada.
Even though we know and use 3D printing resins very well, it is a great pleasure that it is accepted as a registered product and puts an end to the discussions. We will continue to follow the effects and positive developments of 3D printers on human health.