Quebec City, Canada - January 1st, 2015 - Panthera Dental announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Panthera Anti-Snoring Device. This device 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 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 1 5mm in 1 mm increments.
“We are very proud to announce the Panthera Anti-Snoring device to the US market” said 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”.
About Panthera Dental
Headquartered in Quebec City, Canada, Panthera Dental is a world leader in CAD/CAM prosthetic implant solutions and dental sleep appliances. The rapid growth of the company is based on the values that are very dear to us, namely highly attentive customer care, quality products, as well as innovation, and on its collaboration with many key opinion leaders in the dentistry field. Both a pioneer and a leader, Panthera Dental has successfully combined creativity, science and know-how to develop its proprietary innovative technology and is now able to offer next-generation products to the dental industry worldwide.