Overjet, Pearl Second Opinion, Videa and Diagnocat are four FDA-cleared AI tools for dental X-rays, and each one is here for a fact you can check. Overjet has the widest set of FDA clearances (12). Pearl Second Opinion publishes the longest list of named imaging and practice management systems. Videa is cleared to detect caries in patients as young as 3. Diagnocat is the only one of the four cleared to detect a finding on CBCT scans. We compared them on FDA records, published studies, vendor pages and user reviews.
Our picks at a glance
All four tools are FDA 510(k) cleared and all four have pricing on request; they differ most in how many clearances they hold, what those clearances cover, and how much published research names them.
| Tool | Best for | FDA status | Pricing | Evidence |
|---|---|---|---|---|
| Overjet | Breadth of FDA clearances | FDA 510(k) cleared: 12 clearances (May 2021 to August 2026), most recent K261059 | On request (checked October 19, 2026) | Four PubMed studies test or use it, one with Overjet authors; 1 review on Capterra |
| Pearl Second Opinion | A published list of imaging and PMS integrations | FDA 510(k) cleared: eight clearances (March 2022 to November 2025), most recent K250525 | On request (checked October 19, 2026) | Three PubMed studies name it; 4.3 out of 5 from 4 reviews on Capterra |
| Videa | Caries detection cleared from age 3 | FDA 510(k) cleared: four clearances (April 2022 to September 2025), most recent K251002 | On request (checked October 19, 2026) | No published study with its own data; reader studies in VideaHealth’s FDA submissions; no user reviews collected |
| Diagnocat | Periapical radiolucency detection on CBCT | FDA 510(k) cleared: one clearance, K252934 (January 15, 2026), CBCT only | On request; monthly or annual subscription, per the vendor (checked October 19, 2026) | 25 PubMed records name it; no user reviews collected |
Overjet: best for breadth of FDA clearances
Overjet, Inc.’s Vision AI marks suspected caries, calculus, periapical radiolucencies and past restorations on dental X-rays for the dentist to review. The FDA’s 510(k) database lists 12 clearances for Overjet, Inc. between May 2021 and August 2026, more than any other tool on this list.
Those clearances cover a lot of ground, each for one product and a defined use. Caries detection on bitewings and periapicals, interproximal calculus, periapical radiolucencies on periapicals, dental charting, optional image enhancement and an image management system that flags capture problems such as cone cuts all have their own entries. Two clearances reach young children: Overjet Caries Assist-Pediatric (K233738) is for ages 4 to 11, and Overjet Multi-Image Caries and Charting Assist (K261059, August 6, 2026) is for age 4 and older. Overjet CBCT Assist (K251514, December 5, 2025) covers segmentation, measurements and 2D/3D views of CBCT images.
The research is mixed. A 2025 study by authors from George Washington University, the University of Florida, the University of Jordan and Overjet reported 0.91 sensitivity for dentinal lesions on 1,604 bitewing surfaces; its abstract doesn’t say where the radiographs came from. An independent 2026 Journal of Dentistry study from the University of Florida and the University of Sao Paulo, on 27 extracted teeth, found the AI sorted lesion depth less accurately than human readers on the same bitewings, with 56% sensitivity at the dentin threshold against 75% for human-read bitewings.
The main limitation is a gap between the marketing and the records. Overjet says it is FDA-cleared to quantify bone levels, but none of the indications we could read mentions bone levels. Its pages also name no specific PMS or imaging product, and Capterra has a single review. If you want AI marks on every bitewing and periapical plus insurance tools from the same vendor, read our full Overjet review for the clearance-by-clearance table.
Pearl Second Opinion: best for a published integration list
Second Opinion is Pearl Inc.’s AI software that marks suspected caries, calculus, periapical radiolucencies, bone levels and existing restorations on dental X-rays. Pearl is the only vendor of the four that names the imaging and practice management systems it works with: the vendor says 40+ systems, including DEXIS, Carestream, Romexis, Sidexis, Apteryx XVWeb, MiPACS, Open Dental, Eaglesoft, Curve and Dentally.
That list is a vendor claim, but it gives you something concrete to check before a demo. The other three vendors’ pages either say they connect to your PMS and imaging software without naming products, or list no systems at all. Pearl says Second Opinion also runs as a standalone web app.
The FDA’s 510(k) database lists eight clearances for Pearl, Inc., from the original Second Opinion (K210365, March 4, 2022) to Second Opinion Panoramic (K250525, November 14, 2025). They cover bitewings, periapicals and panoramic images, a pediatric version for patients aged 4 and older, bone level measurements and Second Opinion 3D (K243989), which marks anatomy on CBCT scans.
The limits are on CBCT and accuracy. The 3D clearance covers anatomy only, and the vendor says CBCT pathology detection is available in Canada. A 2026 Caries Research study of 200 bitewings, whose abstract doesn’t say where the images came from, found that five commercial systems, Second Opinion among them, missed many caries lesions next to restorations. On Capterra, most reviewers say it helps them explain findings to patients, and two say it isn’t always accurate. Our Pearl Second Opinion review has the full integration list and all three studies.
Videa: best for caries detection cleared from age 3
Videa Caries Assist is VideaHealth, Inc.’s AI software that marks suspected caries on dental radiographs for the dentist to review. Its later clearances, Videa Dental Assist (K232384, December 15, 2023) and Videa Dental AI (K251002, September 19, 2025), cover caries on bitewings and periapicals for patients aged 3 and older, the youngest age in any caries clearance on this list.
VideaHealth, Inc. has four clearances in the FDA’s 510(k) database since April 2022: three for caries detection and one, Videa Perio Assist (K223296), for bone level measurements. Videa Dental Assist and Videa Dental AI also cover other suspected findings, such as calculus and periapical radiolucency, and the 2025 version adds an outline view and a toggle between a high sensitivity and a high specificity setting.
VideaHealth ran the tests itself. In its 2022 FDA submission, a standalone test on 1,034 adult radiographs from 10 US sites found an image-based sensitivity of 70.8%, and in a reader study 21 readers scored higher with the software than without it. These are company-run tests summarized for the FDA, not peer-reviewed studies. We found no published study with its own data on the product; the one PubMed item is a 2023 letter about Videa Perio Assist that gives no figures.
The vendor’s pages are the weak spot: no supported imaging or PMS systems, no BAA and no prices. VideaHealth’s current site also sells a product called Clinical Assist without saying which cleared device sits behind it, so ask. Our Videa Caries Assist review goes through all four clearances and the FDA test results.
Diagnocat: best for periapical radiolucency detection on CBCT
Diagnocat is a cloud-based dental AI platform that analyzes CBCT scans, intraoral X-rays and panoramic images, builds 3D models and drafts reports. Its one FDA clearance (K252934, January 15, 2026) covers aid in detecting periapical radiolucency on CBCT images of permanent teeth in patients 22 and older. Of the four picks, it’s the only clearance that detects a finding on CBCT; the Overjet and Pearl CBCT clearances cover segmentation, measurements and anatomy.
Diagnocat also has the most PubMed records naming it of the four. A PubMed search on October 19, 2026 found 25 records that name it. In a 2025 Journal of Dentistry study by researchers at King’s College London and Taif University, on CBCT scans of 134 molars, Diagnocat’s tooth-level sensitivity for periapical lesions was 93.9% and specificity was 65.2%, and the authors say a clinician needs to check the output to prevent overdiagnosis. On 2D periapicals, a 2025 International Endodontic Journal study of 339 teeth by the King’s College London group found it less sensitive than experienced endodontists (47.9% vs. 65.3%).
Set against the marketing, the clearance is narrow. The vendor says it detects more than 60 conditions on 3D scans and over 40 on 2D images, but 2D analysis and every other condition sit outside the FDA indication. Per the FDA, it’s meant for licensed dental professionals with at least two years of CBCT reading experience. If you’re a US practice, ask which features you can use here. Our Diagnocat review summarizes six of the studies and the subscription terms.
How we chose
We picked these four because they are the imaging AI tools we have reviewed so far, and each review is built from FDA records, PubMed, vendor pages and, where we had them, Capterra reviews. We read those sources and didn’t use the tools ourselves. All sources were checked on October 19, 2026.
The order follows the evidence we could check. First, how much of what each vendor advertises is covered by FDA clearances we could read: Overjet has 12, Pearl eight, VideaHealth four and Diagnocat one. Second, how many published studies name the product. Diagnocat has the most PubMed records, but its single clearance covers one finding on one image type, so it sits last. This isn’t a ranking of clinical accuracy: the studies use different images, findings and reference standards, and their numbers can’t be compared across tools.
For each tool we compared what the FDA summaries say it does, which image types and patient ages they cover, the published studies that name it and who wrote them, what the vendor says about integrations, privacy and pricing, and, for Overjet and Pearl, what Capterra reviewers say. This list has no affiliate links or sponsored placements.
FAQ
Which AI dental X-ray tools are FDA cleared?
All four on this list are FDA 510(k) cleared. The FDA’s database lists 12 clearances for Overjet, eight for Pearl’s Second Opinion, four for VideaHealth and one for Diagnocat (searched October 19, 2026). Each clearance covers specific findings, image types and patient ages, so check that the finding you care about is in one.
Does AI X-ray software replace the dentist’s diagnosis?
No. The FDA summaries for all four describe aids for the dentist, and most of the ones we read say the software isn’t a replacement for the dentist’s own review, patient evaluation, diagnosis or clinical judgment. That includes Diagnocat’s one summary, all four of VideaHealth’s and seven of Pearl’s eight; for Overjet, 10 of 12 say so, one (the 2021 Dental Assist clearance) isn’t readable in our saved copy, and the image enhancement summary doesn’t address it. AI marks are suggestions, and the dentist confirms or rejects each one.
How much do AI dental X-ray tools cost?
Pricing on request for all four. None of the vendors publishes prices on the pages we checked, and each asks you to book a demo. Diagnocat’s FAQ says plans are monthly or annual subscriptions with no pay-per-report option (checked October 19, 2026).
Which AI tools work on CBCT scans?
Three of the four have a CBCT clearance. Diagnocat is cleared to aid detection of periapical radiolucency on CBCT; Overjet CBCT Assist covers segmentation, measurements and 2D/3D views; Second Opinion 3D marks anatomy. Videa’s clearances don’t cover CBCT.
Which one works with my imaging software and PMS?
Only Pearl names systems: the vendor says 40+ imaging and practice management systems, including DEXIS, Carestream, Open Dental and Eaglesoft. Overjet and Diagnocat say they connect to your PMS and imaging software but don’t name products, and Videa’s saved pages list none. Confirm your exact systems with the vendor before you sign.
How accurate are AI dental X-ray tools?
It depends on the study, the image type and the finding. A 2026 Caries Research study of 200 bitewings tested five commercial systems, including Second Opinion and Diagnocat, and found no statistically significant difference in accuracy between them, with moderate sensitivity for caries next to restorations. That one study doesn’t show the tools are equally accurate in general: each pick’s section above gives its own studies, which test different findings on different images. Treat vendor accuracy figures as the vendors’ own claims.
Sources
- 6thSolution: Overjet review, accessed October 19, 2026
- 6thSolution: Pearl Second Opinion review, accessed October 19, 2026
- 6thSolution: Videa Caries Assist review, accessed October 19, 2026
- 6thSolution: Diagnocat review, accessed October 19, 2026
- Overjet: home page, accessed October 19, 2026
- Pearl: Second Opinion product page, accessed October 19, 2026
- Pearl: Second Opinion 3D product page, accessed October 19, 2026
- Videa: home page, accessed October 19, 2026
- Diagnocat: home page, accessed October 19, 2026
- Diagnocat: FAQ, accessed October 19, 2026
- FDA 510(k) K233738, Overjet Caries Assist-Pediatric, accessed October 19, 2026
- FDA 510(k) K251514, Overjet CBCT Assist, accessed October 19, 2026
- FDA 510(k) K261059, Overjet Multi-Image Caries and Charting Assist, accessed October 19, 2026
- FDA 510(k) K210365, Second Opinion, accessed October 19, 2026
- FDA 510(k) K243989, Second Opinion 3D, accessed October 19, 2026
- FDA 510(k) K250525, Second Opinion Panoramic, accessed October 19, 2026
- FDA 510(k) K213795, Videa Caries Assist, accessed October 19, 2026
- FDA 510(k) K223296, Videa Perio Assist, accessed October 19, 2026
- FDA 510(k) K232384, Videa Dental Assist, accessed October 19, 2026
- FDA 510(k) K251002, Videa Dental AI, accessed October 19, 2026
- FDA 510(k) K252934, Diagnocat, accessed October 19, 2026
- openFDA device 510(k) and PMA databases, accessed October 19, 2026
- Performance evaluation of AI-based caries detection technology and its educational training module, Frontiers in Dental Medicine (2025), accessed October 19, 2026
- Comparative evaluation of proximal caries detection methods using human, artificial intelligence, and micro-CT assessments, Journal of Dentistry (2026), accessed October 19, 2026
- AI-Based Clinical Decision Support Systems for Secondary Caries Detection and Staging on Bitewings, Caries Research (2026), accessed October 19, 2026
- Celebrating breakthrough in dental diagnostics … Videa Perio Assist: A correspondence, Health Science Reports (2023), accessed October 19, 2026
- Diagnostic accuracy of an artificial intelligence-based platform in detecting periapical radiolucencies on cone-beam computed tomography scans of molars, Journal of Dentistry (2025), accessed October 19, 2026
- The detection of apical radiolucencies in periapical radiographs: a comparison between an artificial intelligence platform and expert endodontists, International Endodontic Journal (2025), accessed October 19, 2026
- PubMed search: Diagnocat[tiab], accessed October 19, 2026
- Capterra: Overjet reviews, accessed October 19, 2026
- Capterra: Pearl reviews, accessed October 19, 2026
