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Panthera Dental recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Panthera Anti-Snoring Device.
This product is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods.
The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient’s pharyngeal space, improving their ability to exchange air during sleep.
The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the dentist. The maximum protrusion of the device is 15 mm in 1-mm increments.
“We are very proud to announce the Panthera Anti-Snoring device to the US market,” says Jerry Vogel, Executive VP USA of Panthera Dental. “This particular product is one of the smallest, most effective and patient-friendly devices in the market today. The potential and the impact of sleep challenges for the dental industry is enormous and will add significant value to dental practices who can now impact so many patients and their families lives in a completely new way.”