SprintRay Receives FDA 510(k) Clearance for NightGuard Flex

510(k) clearance expands patient access to 3D printed occlusal guards as demand increases during pandemicNightGuard Flex is a dental 3D printing resin clinically formulated for comfort, durability and speed of patient deliveryKey milestone in SprintRay ' s Protect A Smile campaign to combat rising global bruxism ratesLOS ANGELES, Nov. 30, 2021 /PRNewswire/ -- SprintRay Inc., an industry leader in digital dentistry and 3D printing solutions, today announced that the United States Food and Drug Administration (FDA) has granted the Company clearance to market its NightGuard Flex 3D printing resin as a Class II medical device in the United States. The SprintRay NightGuard Flex is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints, and joins SprintRay ' s industry-leading line up of end-to-end dental 3D printing solutions. SprintRay NightGuard Flex resin was developed, in part, to meet the growing demand for night guards due to the COVID-19 pandemic. According to an American Dental Association survey, more than 70 percent of dentists are seeing an increase of patients experiencing teeth grinding and clenching, conditions often associated with stress. SprintRay ' s NightGuard Flex 3D printing material is a flexible resin for 3D printing night guards and splints. NightGuard Flex is designed to deliver the best possible patient experience with high impact strength and wear resistance, comfortable a...
Source: Dental Technology Blog - Category: Dentistry Source Type: news