Desktop Health’s SmileGuard Dental 3D Printing Resin Receives Full FDA 510(k) Clearance –


Desktop Health, a Desktop Metal company, recently announced that its SmileGuard biocompatible light-cure resin has received 510(k) clearance from the United States Food and Drug Administration (FDA). The company will now begin selling the resin to dentists’ offices across the United States and could significantly reduce the time it takes for patients to obtain needed dental and orthodontic equipment by 3D printing it rather than manufacturing it from scratch. traditional way.

Mouth guards printed with SmileGuard on the build plate.

SmileGuard has been in development for over two years, with the goal of developing a material that is not only comfortable for patients to wear, but durable enough that they don’t have to replace their mouthguards every few months. Desktop Health boasts that SmileGuard provides the perfect balance of comfort and strength needed for any bite splint, night guards or mouth guards a dentist might need to prescribe. The material also offers high impact resistance to withstand the grinding, clenching and grinding of a patient’s teeth.

According to Ric Fulop, Founder and CEO of Desktop Metal, he says, “Each year, dentists and orthodontists prescribe millions of bite splints or night guards to prevent patients from clenching and grinding their teeth. These conditions can cause pain, headaches, trouble sleeping and also damage the teeth. When made using traditional techniques, these devices typically require several steps and multiple visits to make the final product. It takes time to diagnose a patient, make impressions, and then custom manufacture for the patient. Now, with this resin, dentists and orthodontists have a fast, easy and reliable way to produce custom devices while the patient waits in the office. This is another milestone in dental innovation.

Resin could be a great tool for dentists to add to their arsenal. The fact that it will reduce typical turnaround times to get a mouthguard for a patient from 2-3 weeks to an hour may be the biggest benefit. Now, all a patient has to do is visit their local dentist, have their mouth scanned, and within an hour have a mouth guard printed to protect them from grinding teeth. teeth. Granted, the guard needs to be polished, but all of this can still be delivered within one business day.

Mouth guard printed with SmileGuard

The resin can also hit the market at the perfect time. This area of ​​dentistry is growing rapidly and 45% of dental labs are already 3D printing oral appliances. If Desktop Health’s SmileGuard resin can break into this booming market, it could provide them with financial flow for years to come.

The new material represents a clear step forward for the dental industry and the 3D printing industry as a whole. With 510(k) clearance from the FDA, it relegitimizes this technology and the benefits that 3D printed biomedical materials can bring. The dental industry has been one of the fastest to adopt 3D printing into its practices and with the progress we are seeing, we are excited to see the next innovation that comes from this field.


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