Through our groundbreaking advancements in imaging hardware and software, we’ve built an easy-to-use, handheld intraoral scanner using advanced OCT technology that is capable of capturing 3D volumes of data — including below the gum line, through fluids, and under the tooth surface.
OCT has been demonstrated to achieve 90% accuracy or greater for caries — without the ionizing radiation of other scanning technologies, such as X-rays or CBCT scanners.1
90%
sensitivity to caries, vs. ~45% with 2D X-rays, with no ionizing radiation.1
Our cutting-edge AI technology uses this incredibly rich, 3D volumetric data to conduct state-of-the-art diagnostics and treatment planning, enabling dentists to diagnose problems earlier and with higher accuracy and visualize that data clearly to help patients better understand their need for care.2
We are developing a dental robotics system with a target of completing restorative procedures an order of magnitude faster and more accurately than any human.3
15 min
target to complete a restorative dental procedure, such as a crown, with only one visit — down from two visits of one hour each with traditional methods.4
Safety is our absolute first priority.
Our robotics system is being designed and rigorously tested to ensure that dentists can safely treat teeth even in the most movement-heavy conditions.5
- Our system combines the sensitivity of OCT with the geometric accuracy of an intraoral scanner. Our OCT captures geometrically accurate OCT data in motion. It is supported by in-house testing and IRB-approved testing at ADA-Forsyth. Traditional OCT requires ~3 seconds for a single frame, with motion artifacts rendering scans unsuitable for intraoral use. Our patented approach leverages motion to ensure geometric accuracy. Furthermore, OCT has the following accuracy in detecting interproximal caries: 87% sensitivity and 86% specificity for enamel caries, and 85% sensitivity and 97% specificity for dentin caries. It is well-documented, including in this referenced study (https://www.nature.com/articles/s41598-020-72838-2) showing the mean sensitivity over the participating examiners of 3D OCT for the detection of dentin caries (Table 1, score 1-2 vs. 3) was 0.85 (+0.13). Our OCT does not currently have 510(k) marketing clearance from FDA, and it is not currently available for sale in the U.S.
- Actual data captures from our system can be combined with CBCT for root and pulp localization. Estimated caries volume location in 3D is determined by our OCT system using Al segmentation that is not currently authorized for marketing by FDA. Our OCT does not currently have 510(k) marketing clearance from FDA, and it is not currently available for sale in the U.S.
- FDA-approved robotic systems in implantology have an accuracy of 1100 microns and claim to improve accuracy of implant dentistry. Restorative dentistry requires higher precision, and our prototypes can cut to 100 microns, which has been demonstrated with in-house testing, and OUS first in human testing. There has not been U.S. based testing under IRB approval or an IDE approved by FDA. Only U.S. based in-house testing has been completed thus far. Our prototypes do not currently have 510(k) marketing clearance from FDA, and they are not currently available for sale in the U.S.
- Restorative procedures include fillings and crowns. For crowns, a typical procedure takes 2 hours and is typically split across a 1.5 hour crown preparation visit and a 30 minute restoration and cementation visit. Our system can prepare teeth in a fraction of the time, and because we simulate the preparation geometry prior to prepping the tooth, we can manufacture the restoration before prepping the tooth. This improvement in workflow appears to allow for a 15-minute restoration visit based our pre-clinical in- house testing. This 15-minute timeframe has not been verified through testing with patients in the U.S. under IRB approval or an IDE approved by FDA.
- We have completed in-house testing, as well as OUS dry run testing on awake moving patients, and a first in-human OUS automated restoration procedure. In all of this testing, our system performed as described. However, such testing has not yet been done in the U.S. under IRB approval or an IDE approved by FDA. This device does not currently have 510(k) marketing clearance from FDA, and it is not currently available for sale in the U.S.