15 December 2021

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SprintRay’s 3-D resin wins FDA nod

Katherine E. Pfaff

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Digital dentistry firm, SprintRay Inc., has received FDA 510(k) clearance for its 3-D printing resin for the NightGuard Flex. The approval allows the company to begin marketing the product, approved as a class II medical device.  

FDA’s clearance allows the company to fabricate dental and orthodontic appliances with its cleared 3-D resin. Applications include splints, mouthguards, and nightguards. Clearance for the resin comes as part of the company’s overall campaign, called Protect a Smile, to improve occlusal wellbeing with 3-D printing, which often reduces hassle and costs for patients. At the same time, the demand for nightguards has increased due to grinding and clenching of teeth, thought to be a result of increased stress levels in patients, according to the company. 

"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 at 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."

Source: https://www.prnewswire.com/news-releases/sprintray-receives-fda-510k-clearance-for-nightguard-flex-301433880.html