BOSTON/October 6, 2022 — Desktop Health 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.”
Traditional analog methods to manufacture night guards require dental impressions that are sent to a lab to produce. At the lab, a splint is thermoformed on a model, which must be created, or it’s milled out of a puck and checked on a model for fit. Then, it must be polished and shipped to the dentist, with the complete turnaround time often averaging 2-3 weeks and requiring multiple patient visits.
With Desktop Health’s digital 3D printing workflow, SmileGuard resin can be used to manufacture night guards in as little as an hour and delivered to the patient the same-day. The patient is scanned in minutes during an office visit, where easy-to-use software enables the device to be designed and printed. Polishing takes just minutes to achieve a high shine.
3D printed bite splints and night guards are a fast growing segment in digital dentistry and one of the top 3 most common 3D printed dental applications. More than 45% of dental labs and clinicians are currently 3D printing bite splints and night guards.2
1JADA, Dental Splint Prescription Patterns: A Survey, 1995
2LMT Retrospective Survey, 2021