Desktop Health, the healthcare arm of Desktop Metal, announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its SmileGuard resin, a light-curable biocompatible material for the 3D printing of strong and flexible bite splints and other orthodontic and dental appliances. Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth guards in the office in as little as one hour, allowing same-day delivery.
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Desktop Health says SmileGuard resin solves a common challenge among 3D printed bite splint solutions in the marketplace today. The company says that among available options on the market, the strongest materials are often uncomfortable for patients, while softer materials are often not as durable.
Desktop Health says that the SmileGuard resin, which was in development for more than two years, offers a ‘superior blend of both strength and comfort’ and are custom fit to a patient’s specific dental profile and needs. It also provides high impact resistance to teeth grinding, clenching, temporomandibular disorders (TMD), and abrasions.
“Every year, dentists and orthodontists prescribe millions 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.
He added: “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 or milled out of a puck and checked on a model for fit. Then, it is polished and shipped to the dentist, with the complete turnaround time often averaging 2-3 weeks and requiring multiple patient visits.
Desktop Health says that with the company’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 on the same day. The scan of the patient is done during an office visit, where the software enables the device to be designed and printed. The polishing takes ‘just minutes’ to achieve a high shine.
Desktop Health said that 3D printed bite splints and night guards are one of the fastest growing segments in digital dentistry and are one of the top 3 most common 3D printed dental applications. According to the company, more than 45% of dental labs and clinicians are currently 3D printing bite splints and night guards.
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