Dental News - X-Nav receives FDA clearance for its navigational tool for implant surgery

Dental Tribune USA

Mon. 8 June 2020

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LANSDALE, Pa., USA: X-Nav Technologies — a medical device company that develops surgical products intended to advance patient care while improving doctor productivity — announced on June 4, 2020, that it has received 510(k) clearance from the U.S. Food & Drug Administration for X-Mark, a new virtual patient registration technology that advances navigated dental implant surgery.

X-Mark enhances the company’s X-Guide Dynamic 3-D Navigation system to give dentists the ability to deliver more accurate dental implant procedures to more patients seeking new teeth.

The navigational tool features breakthrough technology to facilitate virtual-based registration of the patient’s anatomy to a digital treatment plan. Developed to be fast and easy, the dentist will prepare for surgery by marking three virtual anatomy points on the patient’s 3-D scan and then mark the same three live points on the patient at the time of surgery. The X-Guide system will use the X-Mark technology to quickly match the points together to enable live navigated surgery — with accuracy and ease.

X-Mark allows the dentist to provide all the benefits of less-invasive navigated surgery in more case presentations — from single tooth replacement to full mouth edentulous reconstruction.

The X-Guide system fits seamlessly into the dental office and works with all cone beam 3-D scanners, including small field of view. It utilizes the surgeon’s digital plan to provide turn-by-turn guidance during surgery. X-Guide allows the surgeon to visualize precise 3-D movements of the handpiece during osteotomy and implant delivery for more exact placement — like GPS for the dental drill. This delivers better functional and aesthetic results. With X-Guide navigation in the dental practice, more patients can benefit from same-day implant surgery, which is especially helpful as more patients want fast and smooth dental surgery.

Dentists can provide more immediate, more accurate, and less invasive dental implant options with X-Guide navigation.

“Over the past few years, the global dental industry has rapidly embraced the X-Guide dynamic 3-D navigation technology because of its ability to deliver more accurate dental implant outcomes,” said Edward Marandola, president of X-Nav Technologies. “X-Mark virtual registration continues to advance and streamline the way surgeons place dental implants — while improving accuracy and facilitating better immediate restorative results. I am excited to launch X-Mark to expand the capabilities of the XGuide system so our customers can more easily offer navigation surgery to more patients.”

X-Mark for X-Guide is the industry’s first virtual patient registration process for dynamic dental navigation to receive 510(k) clearance from the U.S. Food and Drug Administration. X-Mark has also received CE Mark approval from the European Community, and Health Canada Medical Device License approval. The X-Guide Dynamic 3-D Navigation system is used by dentists in over 35 countries and 20 languages — and still growing.