The FDA approved SprintRay’s NightGuard Flex 3D Printing resin for use as a Class II medical device.
SprintRay announced that the 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.
NightGuard Flex is used to fabricate orthodontic and dental appliances such as mouthguards, nightguards, and splints. It joins SprintRay’s lineup of end-to-end dental 3D printing solutions.
NightGuard Flex 3D printing material is a flexible resin for 3D printing night guards and splints. It features high impact strength and wear resistance and is a comfortable and flavorless material designed for same-day patient delivery.
Additionally, NightGuard Flex eliminates the need for third-party resins, creating a uniform, end-to-end dental 3D printing workflow for dental professionals.
“Nightguards are costly and can take several weeks to get back with traditional production methods using outside sources,” said Amir Mansouri, PhD, chief executive officer of SprintRay. “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.”
Photo courtesy of SprintRay