Desktop Health, a healthcare business within Desktop Metal, has received the US Food and Drug Administration (FDA) 510(k) approval for its SmileGuard resin.

SmileGuard is a light-curable biocompatible material designed for the fabrication of strong and flexible bite splints and other orthodontic and dental appliances.

The resin addresses a challenge among the 3D printed bite sprint solutions in the market, where the strong materials are often uncomfortable, and softer ones are not durable.

Desktop Health said that its SmileGuard offers a combination of both strength and comfort, customised to a patient’s specific dental profile and needs.

In addition, the resin offers high-impact resistance to teeth grinding, clenching, temporomandibular disorders (TMD), and abrasions, said the company.

Desktop Metal founder and CEO Ric Fulop said: “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.

“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.”

According to the traditional analogue methods, manufacturing night guards require sending dental impressions to a lab, where a splint is thermoformed and checked on a model.

The splint is then polished and shipped to the dentist, which would take an average of two to three weeks and requires patients to visit the dentist several times.

Desktop Health said that its digital 3D printing workflow, SmileGuard resin will help manufacture night guards within an hour and deliver it to the patient the same day.

The workflow involves scanning the patient during an office visit, which takes only a few minutes, an easy-to-use software will help design and 3D print the product, followed by polishing.

SmileGuard resin joins a growing portfolio of dental solutions from Desktop Health for both dental labs and dental professionals.

Its portfolio includes Einstein 3D printer, Einstein NanoFit 385 technology Hyperprint technology, Flexcera Base, and Flexcera Smile Ultra+, among others.