SprintRay Receives FDA’s 510(k) Clearance for Its NightGuard Flex

SprintRay has received the FDA’s 510(k) clearance for its NightGuard Flex, a dental 3D printed resin, as a Class II medical device.

The resin, which can be used to fabricate orthodontic and dental appliances such as mouthguards, nightguards and splints, enables “uniform, end-to-end dental 3D printing,” the company said.

The FDA defines Class II medical devices as products that present a moderate to high risk to the patient or user.

The Los Angeles, Calif.-based company says it has seen a growing demand for nightguards during the COVID-19 pandemic.