Desktop Health Receives FDA Clearance for SmileGuard Orthodontic and Dental 3D Printing Resin


Office Healththe health branch of Metal deskannounced today that it has received US Food and Drug Administration (FDA) 510(k) clearance of its SmileGuard resin, a biocompatible, light-cured material for 3D printing strong, flexible bite splints and other orthodontic and dental appliances.

Desktop Health says SmileGuard resin solves a common challenge among 3D printed bite splint solutions on the market today. The company says that of the options available on the market, the stronger materials are often uncomfortable for patients, while the softer materials are often not as durable.

Desktop Health says SmileGuard Resin, which had been in development for more than two years, offers a “superior blend of strength and comfort” and is custom-fitted to a patient’s specific dental profile and needs. It also offers high impact resistance against teeth grinding, clenching, temporomandibular disorders (TMD) and abrasions.

“Each year, dentists and orthodontists prescribe millions of splints or night guards to prevent patients from clenching and grinding their teeth, which can cause pain, headaches, sleep disturbances and also damage the teeth,” said Ric Fulop, Founder and CEO of Desktop Metal. .

He added: “Made with traditional techniques, these devices typically require multiple steps and visits – from the time of diagnosis, impression taking and fabrication, to personalized fitting to the patient. Now dentists and orthodontists have a fast, easy and reliable way to produce custom appliances while the patient waits in the office. This is another milestone in dental innovation.

Traditional analog methods for making night guards require dental impressions that are sent to a lab to be produced. In the lab, a splint is thermoformed or milled from a washer and checked on a model to fit. Then it is polished and shipped to the dentist, with the full turnaround time often averaging 2-3 weeks and requiring multiple patient visits.

Desktop Health says that with the company’s digital 3D printing workflow, SmileGuard resin can be used to make night guards in as little as an hour and delivered to the patient the same day. The patient scan is done during a visit to the office, where the software allows the device to be designed and printed. Polishing only takes a few minutes to achieve a high shine.

Desktop Health said 3D printed bite splints and night guards are one of the fastest growing segments of digital dentistry and are one of the 3 most common 3D printed dental applications. According to the company, more than 45% of dental labs and clinicians are currently 3D printing aligners and night guards.

SmileGuard Resin joins a growing portfolio of Desktop Health dental solutions for dental labs and dental professionals. The brand houses Flexcera, FDA approved materials for removable and restorative indications. Flexcera received CE certification in June 2021.

The portfolio also includes the Einstein 3D printer, which launched earlier this year, as well as Hyperprint technology, which harnesses the power of heat and closed-loop processing to manufacture dental applications to what the company claims is up to 50% faster than its predecessor. .

In July 2021, Desktop Health also announced the acquisition of technology under development for use in an implantable device to repair damaged eardrums.

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