Toronto, Ontario, Canada, September 8, 2016
ClaroNav announces that Navident, its Dental Navigation System, received FDA 510(K) clearance.
ClaroNav Inc. is pleased to announce that it has received 510(K) clearance from the Food and Drug Administration (FDA) to market and sell Navident, its navigation system for dental implantations, in the United States. Using the CBCT image as a map, Navident guides surgeons just like a GPS guides drivers. The dental surgeon plans where implants should be placed in the image and Navident, dynamically tracks the drill and the patient’s jaw providing guidance and feedback.
Headquartered in Toronto, ClaroNav Inc. has been successfully developing and marketing imaging and navigation components and clinical solutions to the global medical community for over 15 years. Navident is the result of close collaboration between ClaroNav Inc. and the University of Toronto’s Faculty of Dentistry.
“While surgical navigation has long been the accepted standard of care in neurosurgery and sinus surgery, its use in the dental field has thus far been limited. Leveraging our proven tracking and image processing components and years of clinical research, we have created a highly accurate, portable and affordable system that we are confident will make the process of restoring missing teeth more predictable, affordable and less painful for American patients.” said Doron Dekel, CEO of ClaroNav Inc.
Navident has been successfully marketed and sold in Europe, Asia and Canada for the past 18 months with great success. A clinical usage study, submitted as part of Navident’s FDA application, asked surgeons from these various regions to provide case reports, accuracy assessments and general feedback on the system. Average reported guided placement accuracy of about 1.0mm at the entry point and apex of the implant, and the highly positive survey results provided strong evidence for the following claims:
- Navident is safe:Usage errors that may lead to incorrect guidance are rare and are caught by the accuracy check prior to drilling.
- Navident is effective: It boosts surgeon’s confidence in the quality and safety of the implantations and enables flapless surgery.
- Navident is easy to use:Users are satisfied or very satisfied with all key aspects of Navident’s design.
To provide effective training of American dentists in the optimal use of Navident, ClaroNav plans to extend its global Dynamic Navigation Society to the US, where it will establish a network of Master Clinical Trainers and conduct regular training courses in all regions of North America.
Jason Pardo, ClaroNav’s VP of Sales and Marketing, added: “Dental treatment in general, and dental implant treatment in particular, changes people’s lives for the better. We are proud to be able to provide a solution that contributes to the accuracy, safety and comfort of the implant treatment and are excited about making it available to the large and sophisticated US dental market. Many American dental surgeons are global leaders in the adoption of new technologies and techniques, so obtaining the privilege of serving their needs has positive implications for the future of Navident in the global market as well.”
About ClaroNav Inc.: ClaroNav (formerly Claron Technology Inc.), founded in 2001, focuses on surgical navigation, offering instrument positioning guidance solutions to clinicians in the treatment of their patients. ClaroNav’s Navident system is setting the standard for surgical navigation technology in the dental industry to make implant treatment safe and secure. The privately-owned, self-funded, company, is represented worldwide by subsidiary offices and authorized distributors and is a trusted partner for many clinics and research institutions.
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