Monday, December 6, 2021

SprintRay Receives FDA 510(k) Clearance for NightGuard Flex


As I stated here recently, I love SprintRay products.  I have been using SprintRay printers in my office for several years now and I am *very* impressed with their performance, quality, and durability.  The printers are, to put it simply, workhorses.  They churn out models, implant surgical guides, occlusal guards, and temporary crowns.

You'll notice the term "occlusal guards" in the above paragraph.  I should specify that the term applies to rigid resin based occlusal guards.  For the non-dentist folks who read the blog I should explain that an occlusal guard is a dental device that a patient wears (normally while sleeping) to protect the teeth from damage caused by clenching and grinding.  I should also explain that  there are 2 types of materials that are used to make these devices.

The first material is hard acrylic.  The idea behind this material is that it is very resilient and can resist strong biting forces that are generated by the patient musculature.  Depending on the material used, hard guides can last for years.  The drawback is that they need to be very well balanced with the biting (occlusal) forces distributed equally.  Basically it needs to be designed and adjusted so that all the teeth touch it equally at the same time.  The main drawback is that patients who are strong grinders can break this material.

The second material, which is what I personally prefer to use, is a softer more rubbery material.  It can act as a "shock absorber" to the teeth, is almost impossible to break, and does not require as much adjustment.

Due to my preference to clinically use softer materials, I was excited to learn that SprintRay recently received FDA 510(k) clearance for a new material Nightguard Flex.  This new resin allows the doctor or the dental lab to 3D print appliances made with a flexible material!  

Here is the info from the SprintRay press release:

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.

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