SprintRay Receives FDA 510(k) Clearance for NightGuard Flex
510(k) clearance expands patient access to 3D printed occlusal guards as demand increases during pandemic
NightGuard Flex is a dental 3D printing resin clinically formulated for comfort, durability and speed of patient delivery
Key milestone in SprintRay's Protect A Smile campaign to combat rising global bruxism rates
LOS ANGELES -- 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 and flavorless material and same-day patient delivery. Additionally, NightGuard Flex drives greater efficiency for dental practitioners by eliminating the need for third party resins and creating uniform, end-to-end dental 3D printing workflows.
"Nightguards are costly and can take several weeks to get back with traditional production methods using outside sources," said Amir Mansouri, Ph.D., CEO of SprintRay. "Today, Sprintray's NightGuard Flex resin has totally changed the patient and doctor experience in the treatment of bruxism and teeth grinding. Our patient-centered design is durable, flexible, more comfortable, and enables faster delivery and greater access for patients to receive their nightguards same-day, through chairside SprintRay 3D printing and at more affordable prices."
This announcement follows the launch of SprintRay's Protect A Smile campaign, a program designed to support occlusal health through 3D printing, as well as SprintRay's North American distribution partnership agreement with Nobel Biocare, which furthers the Company's mission to increase patient access to innovative dental technology solutions.