Denti.AI Detect is Denti.AI Technology Inc.’s radiograph AI that marks uncategorized regions of interest on 2D dental X-rays, which include caries and periapical radiolucency, and helps measure bone levels, for the dentist to review. The FDA cleared it through the 510(k) process on October 6, 2023 (K230144), for patients 22 and older without remaining primary teeth. We found no published study naming the product, so the only test results available are the ones Denti.AI reported to the FDA.
Quick verdict
Denti.AI Detect suits an adult-focused general practice that wants a second reader on bitewings, periapicals and panoramic images, and that may also want AI notes, voice perio charting and auto-charting from the same vendor at a published monthly price. Its FDA record spells out what it does and for whom. The evidence beyond that record is thin: no published study, and no user reviews in our sources.
Before you sign, ask Denti.AI three things. Does the X-ray analysis work with your PMS and imaging software? The pricing page lists it “for supported PMS” without naming which ones. Will Denti.AI sign a business associate agreement (BAA)? And can you see it run on your own radiographs? If you treat children or teens, note that the clearance covers patients 22 and older without remaining primary teeth.
Denti.AI Detect at a glance
Denti.AI Detect is a cloud-based detection aid from Denti.AI Technology Inc., FDA 510(k) cleared in 2023 for adult 2D radiographs. Denti.AI’s pricing page lists FMX and panoramic X-ray analysis inside the OneStop Clinical plan at $399/mo or $3,990/yr, without naming Detect, and the vendor says the plan is HIPAA-compliant without mentioning a BAA (all checked October 19, 2026).
| Vendor | Denti.AI Technology Inc. (Dover, Delaware address on its site; Toronto, Ontario address in its FDA filings) |
|---|---|
| What it does | Marks uncategorized regions of interest on 2D dental radiographs, including caries and periapical radiolucency, as a second reader, and aids measurement of mesial and distal bone levels (FDA indications) |
| Who it’s for | Dentists and dental specialists reading radiographs of patients 22 and older without remaining primary dentition (FDA indications); the vendor says it serves more than 10,000 dental professionals in the United States and Canada |
| Pricing | OneStop Clinical, which lists “FMX and panoramic X-ray analysis for supported PMS”: $399/mo billed monthly or $3,990/yr; OneStop Clinical +: $599/mo or $5,990/yr; no plan named for Detect alone (checked October 19, 2026) |
| FDA status | FDA 510(k) cleared, K230144 (October 6, 2023); companion product Denti.AI Auto-Chart, K222054 (November 22, 2022) |
| HIPAA / BAA | The vendor’s pricing page says “HIPAA-compliant”. A BAA is not mentioned on the saved pages. |
| Integrations | The vendor names Dentrix, Dentrix Ascend, Denticon, CareStack, Open Dental, Eaglesoft, ClearDent, ABELDent, Curve Dental and Oryx “and more” as PMS integrations; no imaging software is named |
| Data checked | October 19, 2026 |
What is Denti.AI Detect?
Denti.AI Detect is software that reads a dental radiograph and marks uncategorized regions of interest for the dentist to look at, which include caries and periapical radiolucency. It also helps measure mesial and distal bone levels for each tooth. The FDA indications call it a Computer-Assisted Detection (CADe) device used “as a second reader” by dentists and dental specialists.
Denti.AI’s 510(k) summary describes a cloud-based, prescription-use product that works on bitewings and periapicals (intraoral) and panoramic images (extraoral). It accepts jpeg, jpg, tiff, tif, png, bmp and DICOM files. Detect looks for two kinds of findings, caries and periapical radiolucency, and the summary reports its bone measurements as CEJ-to-bone and CEJ-to-root distances.
On its home page, Denti.AI sells Detect together with Auto-Chart, a separate FDA-cleared product that charts existing restorations and missing teeth from the same images. The vendor describes the pair this way: “Denti.AI Detect identifies potential issues such as caries, apical radiolucencies, and bone loss, while Denti.AI Auto-Chart populates existing restorative work (crowns, implants, fillings, etc.)”. Denti.AI also makes an AI scribe and voice perio charting; you can read our Denti.AI Scribe review for that side of the company.
Key features
Denti.AI Detect’s features come from two places: the FDA summary, for what the software finds and measures, and Denti.AI’s home and pricing pages, for views, reports and charting:
- Findings: marks uncategorized regions of interest, which include caries and periapical radiolucency, on bitewing, periapical and panoramic images (FDA summary)
- Bone levels: aids measurement of mesial and distal bone levels for each tooth (FDA summary)
- Views: the vendor lists “FMX and tooth-focused views”
- Patient education: the vendor lists “Patient-friendly reports for better education” and says Detect gives “detailed descriptions and patient education”
- Charting: with Auto-Chart, the vendor says confirmed conditions and treatment codes move into your PMS, and that Auto-Chart “reduces clicks by 70%”
- Treatment plans: the vendor lists “Treatment plans, get a second opinion” under Detect and Auto-Chart
- Setup and support: the vendor says setup takes “a few clicks” and its support team “replies within minutes”
Denti.AI Detect vs. what an imaging AI tool should have
Denti.AI Detect covers the FDA side of our imaging checklist well: a cleared use for caries, periapical radiolucency and bone levels, three image types and a dentist-review role written into the clearance. The gaps are on the vendor’s pages, which name no imaging software, no BAA and no PMS list specific to the X-ray features.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance for each advertised finding | FDA listing | Vendor: “caries, apical radiolucencies, and bone loss”. FDA indications: caries and periapical radiolucency as a second reader, and aid in measuring mesial and distal bone levels |
| Works with your imaging software | Partial | The vendor says it integrates with “cloud and desktop PMS and Imaging” but names no imaging system |
| Works with your practice management system | Partial | The vendor names 10 PMS systems “and more”; the pricing page says X-ray analysis is “for supported PMS” and some features depend on your PMS |
| Dentist reviews every finding | FDA listing | Cleared as a second reader; “not intended to replace a complete clinician’s review or clinical judgment” |
| Image types covered | FDA listing | Intraoral (bitewing, periapical) and extraoral (panoramic) 2D radiographs |
| Data protection details | Not listed | The vendor says “HIPAA compliant”; no BAA, security page or certification on the saved pages |
Should have
| Feature | Status | Note |
|---|---|---|
| Published study that names the product | Not listed | PubMed search on October 19, 2026 found none |
| Patient-facing view for chairside explanations | Listed | “Patient-friendly reports for better education” |
| Pediatric use covered | Not listed | The FDA indications cover patients 22 and older without remaining primary dentition |
| Public pricing | Partial | Plan prices are public; no plan is named for Detect alone |
Nice to have
| Feature | Status | Note |
|---|---|---|
| CBCT analysis | Not listed | The clearance covers 2D radiographs |
| Insurance and claims support | Not listed | |
| Practice analytics | Partial | OneStop Clinical + lists “Custom dashboards”; the pages don’t say what they track |
What the research says
No published study naming Denti.AI Detect turned up when we searched PubMed titles and abstracts for “Denti.AI” and “Denti AI” on October 19, 2026. The search returned no results at all. The test results that do exist come from Denti.AI’s own 510(k) summary for K230144, which the company submitted to the FDA.
Standalone test for caries and periapical radiolucency. The summary describes 709 images from 6 US sites, from patients aged 22 to 92. Three independent dentists set the reference answers by consensus. The goal was a lower 95% confidence bound above 0.6 on a combined score called wAFROC AUC, and the software scored 0.737 (95% CI 0.713 to 0.761), so it met that goal.
Standalone test for bone measurements. This test used 193 images from 9 US sites, from patients aged 22 to 88, with three independent dentists and a majority rule. On bitewings, CEJ-to-bone sensitivity was 98.1% and specificity 93%, with a mean absolute error of 0.513 mm. On extraoral (panoramic) images, sensitivity was 91.6% and specificity 84.3%. The summary says every acceptance criterion was met except CEJ-to-bone specificity on periapical images (88.5%), where the lower confidence bound fell slightly short.
Reader study. Twenty-four dental professionals read 154 images from 5 US sites, first without the software and then with it. Their combined score rose from 0.784 to 0.809, a difference of 0.025 (p = 0.029), which the summary calls a statistically significant improvement.
These are company-run tests summarized for the FDA, and we found no published study that checks them. Denti.AI’s home page also claims “26% additional treatment opportunities” and says Detect “will help diagnose more diseases earlier”. The home page doesn’t say where the 26% figure comes from, and it doesn’t appear in the 510(k) summary, so treat it as the vendor’s claim.
FDA status and privacy
The FDA’s 510(k) database lists two clearances for Denti.Ai Technology, Inc. Detect is the radiograph analysis product; Auto-Chart is the charting product the vendor sells alongside it.
| Device | 510(k) | Cleared | What the FDA indications say it does |
|---|---|---|---|
| Denti.AI Detect | K230144 | October 6, 2023 | Assists dentists and dental specialists in detecting regions of interest within the teeth area, including caries and periapical radiolucency, as a second reader on extraoral and intraoral 2D radiographs; aids in measuring mesial and distal bone levels; patients 22 and older without remaining primary dentition |
| Denti.AI Auto-Chart | K222054 | November 22, 2022 | Assists dentists, dental specialists and hygienists in detecting teeth, missing teeth and past restorations (implants, crowns, pontics, endodontic treatment, fillings), choosing treatment options and producing dental charts from 2D X-rays; adults 22 and older without remaining primary teeth |
Both indications end with nearly the same limit. Detect’s says the device is not intended to replace a complete clinician’s review or clinical judgment that considers other relevant information from the image or patient history. Detect’s marks are suggestions; the dentist decides what each one is. Next to that, the vendor describes Detect as an “AI-powered tool for accurate diagnostics of X-rays” and says it is “FDA-cleared, including caries, periapical radiolucencies, bone levels”. We found no PMA records for Denti.AI.
On privacy, the vendor’s pricing page says “HIPAA-compliant” and “HIPAA compliant”, but none of the saved pages mention a business associate agreement, a security page or a certification such as SOC 2. Denti.AI’s privacy policy, last updated March 26, 2026, covers its website and the Denti.AI Voice Assistant. It says data may be processed outside your state or country and that analytics services such as Google Analytics, Datadog and Mixpanel collect log data from visitors. It doesn’t mention HIPAA or radiographs. Ask for a signed BAA before you send patient images.
Pricing
Denti.AI’s pricing page, checked October 19, 2026, doesn’t name Detect, but its OneStop Clinical plan lists “FMX and panoramic X-ray analysis for supported PMS” and Auto-Chart. That plan costs $399 a month billed monthly or $3,990 a year billed annually, for up to 7 installs at one location with unlimited users. It also includes AI notes, voice perio charting, oral health summaries, referral letters and coaching.
OneStop Clinical + costs $599 a month or $5,990 a year and adds custom dashboards and unlimited installs at one location. The page says there is no setup fee, that “Some features depend on your practice management system”, and that multi-location DSOs should talk to sales. If you only want X-ray analysis, ask whether Denti.AI sells it on its own, because the saved page doesn’t show that option.
Who it’s for
Denti.AI Detect fits a single-location practice that treats adults, uses one of the PMS systems Denti.AI names, and wants an FDA-cleared second reader for caries, periapical radiolucency and bone levels bundled with notes and perio charting. You can see the monthly price before you call sales.
Look elsewhere, or ask more first, if a large share of your patients are under 22, need CBCT analysis, or want independent published evidence before you buy. The same goes if you need a named imaging integration or a signed BAA in writing before a demo.
FAQ
Is Denti.AI Detect FDA cleared?
Yes. The FDA’s 510(k) database lists Denti.AI Detect as cleared on October 6, 2023 (K230144). The cleared use is to assist dentists, as a second reader, in detecting uncategorized regions of interest that include caries and periapical radiolucency, and to aid bone level measurements on 2D radiographs of patients 22 and older without remaining primary teeth.
How much does Denti.AI Detect cost?
Denti.AI doesn’t list a price for Detect alone. Its OneStop Clinical plan, which includes FMX and panoramic X-ray analysis for supported PMS, costs $399 a month billed monthly or $3,990 a year (checked October 19, 2026). OneStop Clinical + costs $599 a month or $5,990 a year.
Does Denti.AI Detect work with my PMS?
Possibly; ask Denti.AI to confirm. The vendor names Dentrix, Dentrix Ascend, Denticon, CareStack, Open Dental, Eaglesoft, ClearDent, ABELDent, Curve Dental and Oryx as integrations, but its pricing page offers X-ray analysis only “for supported PMS” and doesn’t say which. No imaging software is named on the saved pages.
How accurate is Denti.AI Detect?
No published study gives a figure. In Denti.AI’s own FDA submission, the software scored 0.737 on a combined detection score in a test of 709 images from 6 US sites, and 24 dental professionals reading 154 images scored 0.809 with it against 0.784 without it. These are company-run tests summarized for the FDA.
Does Denti.AI Detect diagnose on its own?
No. The FDA indications describe a second reader and say the device is not intended to replace a complete clinician’s review or clinical judgment. The dentist reviews every mark and makes the diagnosis.
Will Denti.AI sign a BAA?
The saved pages don’t say. Denti.AI’s pricing page says the plans are HIPAA-compliant, but no page mentions a business associate agreement, so ask for one in writing before you connect patient radiographs.
How this review was put together
We didn’t use Denti.AI Detect. This review is built from Denti.AI’s home, pricing and PMS integration pages and its privacy policy, the FDA’s 510(k) and PMA databases (searched for “Denti.AI” and “Denti AI”) with the K230144 and K222054 decision documents, and a PubMed search. We didn’t collect any user reviews for this product. All sources were checked on October 19, 2026.
Sources
- Home page (Denti.AI), accessed October 19, 2026
- Pricing page (Denti.AI), accessed October 19, 2026
- PMS integrations page (Denti.AI), accessed October 19, 2026
- Privacy policy (Denti.AI), accessed October 19, 2026
- FDA 510(k) K230144, Denti.AI Detect (decision document), accessed October 19, 2026
- FDA 510(k) K222054, Denti.AI Auto-Chart (decision document), accessed October 19, 2026
- openFDA device 510(k) and PMA databases (search of Denti.AI), accessed October 19, 2026
- PubMed search for “Denti.AI” OR “Denti AI” (title and abstract), accessed October 19, 2026
