LANSDALE, Pa., Oct. 15, 2015 /PRNewswire/ -- X-Nav Technologies, LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the X-Guide™ Dynamic 3D Navigation system. The X-Guide system is designed to elevate the surgeon's control and precision over the entire implant process, including planning and placement. This results in the ability to deliver a more desirable functional and aesthetic outcome in dental implant surgeries.
According to the American Academy of Implant Dentistry, 3 million Americans have dental implants to replace missing teeth and that number is growing by 500,000 a year.
The X-Guide™ system utilizes the surgeon's plan to provide turn-by-turn guidance during live surgery, giving the ability to visualize precise movements of the handpiece during osteotomy and implant delivery for more exact placement – it's like GPS for the drill.
"Just as cone beam 3D imaging has transformed dental implant procedures for surgeons and patients, this next advancement in technology will bring more precision and control in transferring 3D treatment plans to the patient, with ease," said Ed Marandola, X-Nav Technologies President & CEO.
The X-Guide system makes it easy to be exact by providing robust treatment software plus new, patent-pending X-Point™ navigation technology – the first, single-view guidance of implant position, angle and depth. Compatible with most Cone Beam 3D systems, surgeons do not have to stop at precise planning anymore – now they can place in remarkable detail as well. With the X-Guide system in the dental practice, same-day guided surgery can be a reality for more patients. This is a big advantage, as more patients want their implant results to be functional and aesthetic, while minimizing complications and optimizing their time.
Developed in close collaboration with leading Oral and Maxillofacial Surgeons, the X-Guide system promises to deliver what today's implant clinicians want. Dr. Robert W. Emery, Diplomate of the American Board of Oral and Maxillofacial Surgeons states, "the X-Guide system fills the final gap of digital dentistry. Dynamic 3D navigation allows the dentist to use all the 3D digital information at their fingertips in real-time to immediately use their Cone Beam 3D scan to plan and place implants."
X-Nav Technologies has received clearance to market and sell the X-Guide Dynamic 3D Navigation system to dental clinicians in the United States, Canada and the European Community. For more information please visit www.X-NavTech.com
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About X-Nav Technologies, LLC
X-Nav Technologies is a medical device company in Lansdale, PA that develops surgical products for the dental market that advance patient care while improving doctor productivity. www.X-NavTech.com.
SOURCE X-Nav Technologies