Wednesday, June 1, 2022

X-Guide Dynamic Navigation Receives FDA 510(k) Clearance To Aid in Minimally Invasive Endodontic Procedures

As 3D burrows more and more into the every day practice of dentistry, we are seeing more and more application development that can combine 3D with procedures that become streamlined with the ability to "see everything".  In the last year or so, I've heard rumblings of using CBCT scan to help create the ideal access for endodontic treatments both in traditional endodontics as well as root end type procedures.  While not every case would benefit from this, I can certainly see cases where this would provide a tremendous advantage and benefit.  Here is a press release for a recently FDA 510(k) approved endodontic guide system.


X-Nav Technologies, LLC, a leading creator of image-guided and robot-assisted surgical products, announced that is has received clearance from the U.S. Food and Drug Administration to expand the use of its X-Guide® Dynamic Surgical Navigation system to aid dentists in delivering minimally invasive endodontic procedures.

With X-Guide dynamic navigation, patients and dentists can now benefit from more precise and minimally invasive access to tooth structures needing endodontic treatment – specifically, access to calcified canals and apicoectomies of affected teeth.

"X-Guide dynamic navigation is an extremely accurate solution to a common endodontic challenge: calcified root canal systems," according to L. Stephen Buchanan, DDS, FICD, FACD of Santa Barbara, CA. "With X-Guide, I can perform minimally invasive root canal therapy (RCT) with much more predictability and less stress."

Using the X-Guide system's patented X-Point™ technology, the dentist gains a live view of the patient's 3D anatomy and a digital handpiece to guide drill movements during surgery. This allows the dentist to precisely navigate their drill to an exact access location for more efficient endodontic procedures. Tools in the X-Guide software help make navigation easy to integrate into the endodontic workflow, like the virtual Prep feature for planning and following an ideal drill path, X-Mark™ virtual registration for using small, medium and large field of view CBCTs, and integration with high-speed handpieces.

Combining 3D imaging with X-Guide navigation allows dentists to locate and access endodontic tooth structures more precisely, which is useful to:

achieve less invasive access and prep of calcified and hidden canals

perform minimally invasive apicoectomy and root-end access

minimize damage to anatomical structures

preserve tooth structure

save time and potentially reduce intra-operative imaging

"In teeth with calcification, X-Guide dynamic guidance can be used to reduce structural weakening through minimally-invasive endodontic procedures," stated Dr. Charles Maupin, DDS of Lubbock, TX.

According to studies, "The dynamic navigation system was more accurate and more efficient in root-end resection in a cadaver model than the freehand technique. The dynamic navigation system has the potential to be a safe and reliable technological addition to endodontic microsurgery."1

Dr. Frederico Martinho, DDS, M.Sc., PhD, and Clinical Associate Professor at the University of Maryland School of Dentistry, shared that "Our recent studies with X-Guide focused on minimally invasive access cavity, post removal, locating calcified canals, and endodontic microsurgery. It has the potential to improve accuracy, reduce surgical time, and operator mishaps. Both the endodontic residents and I were able to quickly master the technology – the learning curve was not steep for novel or experienced endodontists."

The X-Guide system has gained global recognition for giving dental surgeons the ability to perform more accurate and precise dental implant procedures, compared to freehand surgery. Over 175,000 dental implants have been surgically placed using the X-Guide system around the world.

"As X-Guide surgical navigation became an integral part of dental implant surgery, it also became clear that expanding access to our technology for endodontic procedures would improve provider capabilities and patient experiences. I'm proud of our talented team of clinical and engineering masterminds for being able to deliver the benefits of surgical navigation to more dental professionals," said Edward Marandola, President, CEO, and Co-Founder of X-Nav Technologies.     

To read more about the benefits of X-Guide® Dynamic Surgical Navigation for single implants, full arch reconstruction and endodontics, please visit         

About X-Nav Technologies
X-Nav Technologies is a medical device company that develops surgical products for the dental market that advance patient care while improving doctor productivity.

1Accuracy and efficiency of guided root-end resection using a dynamic navigation system: a human cadaver study. O Dianat, A Nosrat, B Mostoufi, JB Price, S Gupta, FC Martinho. PMID 33368371, DOI:10.1111/iej.13466

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