Desktop Health Receives FDA Clearance for SmileGuard Resin

Desktop Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new SmileGuard™ resin. SmileGuard is said to be a breakthrough light-curable biocompatible material for the fabrication of strong and flexible bite splints and other orthodontic and dental appliances, according to a press release from the company.

SmileGuard is designed to solve an industry-wide challenge: many of the strongest materials may be uncomfortable to patients, while softer materials may not be as durable. SmileGuard is said to offer a blend of strength and comfort and is custom-fit to a patient’s specific needs. It also offers high-impact resistance to teeth grinding, clenching, temporomandibular disorders, and abrasions, the press release stated. It is indicated for the 3D printing of splints, night guards, and mouth guards in-office.

Traditionally, the analog manufacturing of night guards would require sending dental impressions to a lab to produce, with turnaround times sometimes requiring a couple of weeks and 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 patients the same day, according to the press release.