LAS VEGAS, Nev., USA: X-Nav Technologies, the developer of advanced technology solutions for dental surgery, has announced 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.
Interactive, turn-by-turn guidance during live surgery gives the ability to visualize precise movements of the handpiece during osteotomy and implant delivery for more exact implant placement; according to the company, it’s like GPS for the drill. This results in the ability to consistently deliver a more desirable functional and esthetic outcome in dental implant surgeries.
X-Nav Technologies confirms that it has approval to market and sell the X-Guide Dynamic 3D Navigation system to dental clinicians in the United States, Canada and the European community.
“Just as cone-beam 3-D imaging has transformed the dental implant process for surgeons and patients, this next advancement in technology will bring more precision and control in transferring 3-D treatment plans to the patient, with ease,” said Ed Marandola, X-Nav Technologies president and CEO.
The X-Guide system makes it easy to be exact, the company says, by providing robust and easy-to-use treatment software plus new, patent-pending X-Point navigation technology — the first, single-view guidance of implant position, angle and depth.
The X-Guide system is designed to be compatible with most cone-beam 3-D systems, X-Nav Technologies asserts, adding that surgeons do not have to stop at precise planning anymore — now they can place in remarkable detail as well.
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: “X-Guide fills the final gap of digital dentistry. Dynamic 3-D navigation allows dentists to use all the 3-D digital information at their fingertips in real-time to immediately use their cone-beam 3-D scan to plan and place implants. The surgeon can fully guide his or her cases even when clinical alterations are necessary because the system embraces flexibility.”
The X-Nav Technologies leadership includes part of the original team that brought industry-leading i-CAT cone-beam 3-D imaging to the dental industry.
The president and co-founder of X-Nav, Ed Marandola, is the former president and co-founder of i-CAT (Imaging Sciences International), and X-Nav co-founder Chris Scharff led the i-CAT commercial team as vice president.
(Source: X-Nav Technologies)
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