SprintRay’s NightGuard Flex resin receives FDA clearance

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SprintRay’s NightGuard Flex 3D-printing resin receives FDA clearance

According to SprintRay, the FDA 510(k) clearance will help expand patient access to 3D-printed occlusal guards as demand increases during the pandemic. (Image: SprintRay)


Wed. 5. January 2022


LOS ANGELES, US: As 3D printing in dentistry evolves to become industry standard, the need for access to more materials is critical. In a step that 3D-printing company SprintRay calls a “key milestone”, the US Food and Drug Administration has granted the company clearance to market its NightGuard Flex 3D-printing resin as a Class II medical device in the US.

Used to fabricate appliances such as mouth guards, night guards and splints, the resin joins SprintRay’s growing number of end-to-end dental 3D-printing solutions. Designed to provide the best possible patient experience with high-impact strength and wear-resistance, NightGuard Flex also allows same-day patient delivery, eliminates the need for third-party resins and creates uniform, end-to-end dental 3D-printing workflows.

According to SprintRay, the resin was developed, in part, to help meet the increasing demand for night guards. The COVID-19 pandemic has induced extra stress and worry, and a March 2021 survey conducted by the American Dental Association indicated that more than 70% of dentists were seeing a rise in the number of patients experiencing bruxism. In a press release, SprintRay CEO Dr Amir Mansouri said, “SprintRay’s NightGuard Flex resin has totally changed the patient and doctor experience in the treatment of bruxism and teeth grinding.”

The pandemic is still having an impact on the global community, and innovation within dentistry will be vital in ensuring that the needs of patients can be met with few difficulties and at competitive prices. This recent announcement from SprintRay comes after the company demonstrated its commitment to supporting occlusal health through its Protect a Smile campaign and after its North American distribution partnership agreement with Nobel Biocare, which as reported by Dental Tribune International, will result in reduced implant delivery times.

“Our patient-centred design is durable, flexible, more comfortable, and enables faster delivery and greater access for patients to receive their night guards same-day, through chairside SprintRay 3D printing and at more affordable prices,” noted Dr Mansouri.

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