Desktop Health receives FDA clearance for SmileGuard orthodontic and dental 3D printing resin

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.

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.

The SmileGuard resin joins a growing portfolio of Desktop Health dental solutions for both dental labs and dental professionals. The brand is home to Flexcera, FDA-cleared materials for removable and restorative indications. Flexcera received CE certification in June 2021.

The portfolio also includes the Einstein 3D printer, which was launched earlier this year, along with Hyperprint technology, which harnesses the power of heat and closed-loop processing to fabricate dental applications at what the company claims is up to 50% faster than its predecessor.

In July 2021, Desktop Health also announced the acquisition of a technology that is being developed for use in an implantable device for repairing damaged eardrums.

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