Quebec City, Canada - January 5th, 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 t 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 tting 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” said Jerry Vogel, Executive VP USA of Panthera Dental. “This particular product is one of the smallest, most elective 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 signicant 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 arevery 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 eld. 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 oer next-generation products to the dental industry worldwide.