SprintRay received FDA 510(k) clearance to market a printing resin used in the manufacturing of orthodontic and dental appliances, the dental 3D printing company said Nov. 30.
NightGuard Flex can be used to make mouth guards, night guards and splints, the company says. The clearance allows Los Angeles-based SprintRay to market the resin as a Class II medical device in the U.S.
The company said it developed the resin in response to growing demand for night guards during the COVID-19 pandemic.