www.fdanews.com/articles/197612-x-nav-technologies-implant-navigation-tool-gets-fda-clearance
X-Nav Technologies’ Implant Navigation Tool Gets FDA Clearance
June 15, 2020
Pennsylvania-based X-Nav Technologies received 510(k) clearance from the FDA for its X-Mark, a virtual technology tool used to improve accuracy in dental implant procedures.
Used in tandem with the company’s X-Guide surgical navigation system, the 3D technology allows dentists to mark three virtual anatomy points on a patient’s 3D scan, then marks the same three points on the patient at the time of surgery and guides the surgical tool.
The X-Mark previously received CE mark certification in Europe.