Myofunctional Research Co. - FDA 510(k) Cleared Devices

Myofunctional Research, Co. develops intraoral appliance systems and education programs for treating breathing, myofunctional, and orthodontic disorders. The company operates with a manufacturing facility in Helnsvale, Australia, and serves dental and medical practitioners globally across more than 100 countries.

The company has received 1 FDA 510(k) clearance from 1 total submission. Dental devices represent 100% of the company's regulatory submissions. The latest clearance was granted in 2026, confirming active regulatory engagement.

MRC's product portfolio includes the Myosa system for breathing and myofunctional disorder treatment, along with complementary appliance lines designed for myofunctional orthodontics, TMJ dysfunction, and arch development. The company's approach emphasizes non-invasive, prefabricated solutions that address underlying causes rather than symptoms alone.

Explore the company's cleared device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Dba the Eyedeas Company as regulatory consultant.