BOSTON– Desktop Health, a healthcare business within Desktop Metal, Inc. (NYSE: DM) committed to developing 3D printing solutions for personalized medicine, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of SmileGuard resin, a breakthrough light-curable biocompatible material for the fabrication of strong and flexible bite splints and other orthodontic and dental appliances.
SmileGuard resin, which is now available for ordering and shipping, solves a challenge among 3D printed bite sprint solutions in the marketplace today. Among the available options, the strongest materials are often uncomfortable to patients, while softer materials are often not as durable.
In development for more than two years, SmileGuard resin, however, offers a superior blend of both strength and comfort, custom fit to a patient’s specific dental profile and needs. At the same time, it offers high impact resistance to teeth grinding, clenching, temporomandibular disorders (TMD), and abrasions.
“Every year, dentists and orthodontists prescribe millions1 of bite splints or night guards to prevent patients from clenching and grinding their teeth, which can cause pain, headaches, sleep disruption and also damage teeth,” said Ric Fulop, Founder and CEO of Desktop Metal. “Made with traditional techniques, these devices typically require several steps and visits – from the time to diagnose, make an impression and manufacture, to the custom-fitting to the patient. Now dentists and orthodontists have a fast, easy and reliable way to produce custom-made devices while the patient waits at the office. This is another milestone in dental innovation.”
