ClaroNav Inc. announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the 3rd generation of Navident (Navident 3), its dental surgery navigation system. This expands the earlier clearance of Navident to include guiding the treatments of fully edentulous (toothless) jaws, the use of additional CT-to-jaw registration methods, and a set of reusable accessories supporting these methods.
Navident 3 has increased versatility that enables it to guide the drilling for implant placement in practically any jaw, as well as reduce pre-surgical preparation time and procedure costs.
The innovative registration methods cleared include trace registration, touch registration, and NaviBite registration.
The reusable new tools include a tracer and several types of reusable jaw trackers that enable Navident to track jaw motions in a minimally intrusive manner.
“By widening its indications for use to include any patient with missing teeth, including the 10 percent of US population that is missing all of their teeth, this clearance will make it even more compelling for American dental surgeons to integrate Navident into their daily workflow.” said Jason Pardo, Global VP of Sales and Marketing for ClaroNav. “Navident, with its highly innovative Trace-and-Place and Touch-and-Place workflows, facilitates same day surgery and full arch restoration, providing the fast and efficient precision dentistry that many of these patients are looking for and can now benefit from.”
“Since the previous FDA clearance in 2016, we have, in response to user feedback, greatly improved Navident’s design with many unique innovations and inventions (6 US patents issued or pending since 2016).” said Doron Dekel, ClaroNav’s Co-CEO. “As part of the development, we have made a large investment in testing and benchmarking the upgraded system to ensure its safety and effectiveness in the wide range of clinical situations it may encounter in practice. I am pleased that, following a thorough review of our quality assurance measures, the FDA cleared our application. I am also pleased that we are able to make all these design improvements available at an incremental cost to all our American customers, even those who bought their system back in 2016.”
A breakthrough in computer-aided dental surgery, Navident offers dental practices an easy to use, accurate, highly portable and affordable way to plan the desired restoration and implant placement on a virtual patient, then execute the plan on the real patient’s jaw.
ClaroNav is dedicated to the development of surgical navigation solutions. It’s products/divisions; Navident, Navient/Cranial, NaviX/OEM and the MicronTracker camera are all thriving global businesses with the ultimate goal of helping practitioners and their patients live better lives.