VELMENI for DENTISTS is Velmeni, Inc.’s AI software that marks suspected caries, restorations, fixed prostheses, implants and anatomy on dental radiographs, and anatomy on CBCT scans, for the dentist to review. The FDA’s 510(k) database lists four clearances for Velmeni, the latest a 3D (CBCT) version cleared on July 23, 2026, even though the footer of the vendor’s own site still says the 3D features are for research only and undergoing FDA clearance. Pricing is on request.
Quick verdict
VELMENI suits a practice that wants FDA-cleared AI marks on bitewings, periapicals and panoramics, plus CBCT anatomy, from one web-based platform. The FDA record is solid: four 510(k) clearances between 2024 and 2026, all for patients 15 and older. A 2026 published study of its bitewing results adds evidence, though three of its authors are listed at VELMENI Inc.
Where it falls short is the vendor’s own information. Its saved pages name no PMS or imaging integrations, say nothing about a BAA, give no prices, and contradict themselves about 3D clearance. Before you sign, ask Velmeni which of its products are covered by which clearance, whether VELMENI BRIDGE connects to your PMS and image viewer, and whether it will sign a business associate agreement (BAA).
VELMENI at a glance
Velmeni, Inc., based in Sunnyvale, California, per its FDA filings, runs VELMENI as a cloud-hosted radiograph AI you open in a browser. It has four FDA 510(k) clearances, the most recent for CBCT on July 23, 2026. Pricing is on request, and the vendor’s saved pages don’t mention a BAA (checked October 21, 2026).
| Vendor | Velmeni, Inc. (Sunnyvale, California, per its FDA filings) |
|---|---|
| What it does | Marks suspected caries, restorations, fixed prostheses, implants, tooth and jaw anatomy, bone levels and root canal treated teeth on 2D radiographs, and anatomical structures on CBCT scans, for the dentist to review |
| Who it’s for | Dentists (the vendor’s tagline is “Designed for Dentists”) |
| Pricing | Pricing on request (checked October 21, 2026) |
| FDA status | FDA 510(k) cleared: VELMENI for DENTISTS (V4D), K240003 (August 30, 2024); most recent, VELMENI for DENTISTS (V4D) 3D, K254096 (July 23, 2026) |
| HIPAA / BAA | Not stated on the vendor’s site |
| Integrations | Not listed on the saved vendor pages. The FDA summaries describe VELMENI BRIDGE, which exchanges data with third-party patient management or imaging software. |
| Data checked | October 21, 2026 |
What is VELMENI?
VELMENI is a web application from Velmeni, Inc. that sends your radiographs to a cloud AI engine and returns marked-up images for the dentist to check. The vendor sells the 2D and 3D radiograph tools as VELMENI for DENTISTS, alongside other products for voice perio charting, claims and CBCT.
Velmeni’s FDA summaries describe how the 2D version works. A radiograph type classifier sorts the image, detection modules look for findings, a tooth numbering module labels the teeth, and the results come back as outlines or boxes over the image. The 2D engine takes grayscale images as JPEG or PNG files. For 3D, the 2026 summary says DICOM scans are uploaded in .zip format, and the web app runs in Safari, Edge, Chrome and Firefox.
The vendor’s home page calls VELMENI the “industry’s only unified AI platform integrating 2D & 3D imaging, claims, & voice capabilities.” It lists six products: VELMENI for DENTISTS 2D, VELMENI for DENTISTS 3D, VELMENI Voice (perio chart), 3D Verify, VELMENI for Claims and EasyRiter (cone beam). Apart from the 2D and 3D tools, the saved pages give little more than a name and a short label for each.
Key features
VELMENI’s radiograph features, as the FDA summaries describe them, cover restorative findings, anatomy and bone levels on 2D images and anatomy on CBCT. The vendor’s site adds VR viewing and several products it doesn’t describe in detail:
- 2D detection (2024 and 2025 clearances): dental caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs
- Endo-Perio (2026 clearance): tooth anatomy (enamel, dentine, pulp, root), jaw anatomy (mental foramen, inferior alveolar canal, maxillary sinus), bone level landmarks and root canal treated teeth on the same three image types; the summary says users can edit the outlines and bone level landmarks
- 3D (2026 clearance): maxilla plus cranium, mandible, mandibular canal, TMJ, maxillary sinus, teeth and airway on CBCT scans, with tooth numbering, a panoramic viewer and STL file export that the summary labels “For educational and research purposes only; not intended for 3D printing or treatment planning”
- Rejection Review: the FDA summaries say this module records findings dentists reject, for future product work and post-market surveillance
- A Predetermined Change Control Plan (2025 clearance), which sets out how Velmeni may retrain its 2D detection models and when an update can ship
- VR dentistry: the vendor says you can “manipulate and evaluate 3D/CBCT imagery” in VR and use it for patient education
- VELMENI Voice, VELMENI for Claims, 3D Verify and EasyRiter: named on the vendor’s product page with labels only (perio chart, claims, 3D, cone beam); the home page says you can submit VELMENI’s findings “to receive fewer rejected claims”
VELMENI vs. what an imaging AI tool should have
VELMENI covers the FDA side of our imaging checklist well, CBCT included. The gaps are on the vendor’s pages: no named PMS or imaging integrations, no BAA or security details and no prices.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance for each advertised finding | Partial | 2D findings and CBCT anatomy are cleared; Voice, Claims, 3D Verify, EasyRiter and VR are not in the FDA entries, and the 3D page lists treatment planning among its uses |
| Works with your imaging software or sensors | Partial | FDA summaries describe VELMENI BRIDGE and JPEG, PNG and DICOM input; no list of supported viewers or sensors on the saved pages |
| Works with your practice management system | Partial | FDA summaries say VELMENI BRIDGE exchanges data with patient management software; no systems named |
| Dentist reviews every finding | FDA listing | Cleared as concurrent-read detection aids, not a replacement for the dentist’s examination or judgment |
| Image types covered | FDA listing | Bitewing, periapical and panoramic radiographs, plus CBCT |
| Data protection details | Not listed |
Should have
| Feature | Status | Note |
|---|---|---|
| Published study that names the product | Study | 2026 study of 407 bitewings, Science Progress |
| Patient-facing view for chairside explanations | Partial | The vendor mentions VR and 3D views for patient education |
| Pediatric use covered | Partial | All four clearances cover patients 15 years of age or older |
| Public pricing | Not listed |
Nice to have
| Feature | Status | Note |
|---|---|---|
| CBCT analysis | FDA listing | K254096, anatomical structures on CBCT |
| Insurance and claims support | Listed | VELMENI for Claims, named without details |
| Practice analytics | Not listed |
What the research says
One published study names VELMENI: a 2026 retrospective study in Science Progress that tested the AI on 407 bitewing radiographs from 315 adult patients against two oral and maxillofacial radiologists. PubMed, searched on October 21, 2026, returned two other papers that didn’t name the product. Velmeni’s FDA submissions add company-run test results.
The 2026 Science Progress study. The abstract describes “an AI system developed by VELMENI Inc.” and compares it with tooth-level labels from two oral and maxillofacial radiologists, across 2,829 tooth-level observations. It doesn’t say where the radiographs came from. Most authors are listed at dental schools in the US (University of Mississippi Medical Center, University of Missouri-Kansas City), India and Brazil, but three, including Velmeni CEO Mini Suri, are listed at VELMENI Inc. The paper declares no conflicts of interest. Agreement between the AI and the radiologists (Cohen’s kappa) was 0.812 to 0.871 for restorations, 0.882 to 0.940 for prostheses, 0.763 to 0.974 for implants and 0.454 to 0.508 for caries. After filtering for human consensus, sensitivity was 1.000 for implants, 0.984 for prostheses, 0.974 for restorations and 0.972 for caries. Specificity was 1.000 for implants, 0.984 for prostheses, 0.936 for restorations and 0.842 for caries. The authors conclude its performance was comparable to the radiologists for restorations, prostheses and implants, and “slightly lower for caries detection.”
The 2024 FDA submission (2D, K240003). In Velmeni’s standalone test on 600 bitewing, 597 periapical and 600 panoramic images, labeled by three US licensed dentists with an oral radiologist settling disagreements, lesion-level caries sensitivity was 72.8% on bitewings, 70.6% on periapicals and 68.3% on panoramics. In a reader study, 12 US licensed dentists read the same images with and without the software. Their caries score (wAFROC AUC) rose from 0.794 to 0.848 on bitewings, 0.721 to 0.814 on periapicals (11 readers, since one lacked complete results) and 0.579 to 0.615 on panoramics. Velmeni’s summary also shows trade-offs: with the software, case-level caries specificity on periapicals fell from 94.5% to 84.2%, and restoration specificity on panoramics fell from 96.2% to 85.8%.
The 2026 FDA submissions (Endo-Perio and 3D). The Endo-Perio summary reports sensitivity above 85% for tooth anatomy on bitewings and periapicals, and a mean absolute bone level error of 0.25 to 0.47 mm against a 0.5 mm goal. For the mental foramen on panoramics, sensitivity was 81.5% with a p-value of 0.220, while the mandibular canal and maxillary sinus both reached 99.8%. The 3D summary tested 127 CBCT scans from 4 US dental offices; sensitivity ranged from 96.8% (mandibular canal) to 100.0% across structures, and overall tooth labeling accuracy was 98.6%.
Velmeni ran these tests itself: they are company test results summarized for the FDA, not published studies. Its website claims bigger gains: detection accuracy up 30%, up to 25 hours a week less workload, a 30% faster implant workflow, a 6% revenue uplift and 22% higher case acceptance. The site doesn’t say where these figures come from, and they don’t appear in the FDA summaries.
FDA status and privacy
The FDA’s 510(k) database lists four clearances for Velmeni, Inc., three for 2D radiographs and one for CBCT. All cover permanent teeth in patients 15 years of age or older, and none is a PMA approval:
| Device | 510(k) | Cleared | What the FDA summary says it does |
|---|---|---|---|
| Velmeni for Dentists (V4D) | K240003 | August 30, 2024 | Assists dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses and implants in digital bitewing, periapical and panoramic radiographs |
| VELMENI for DENTISTS (V4D) | K250753 | September 2, 2025 | Same indications as K240003, adding a Predetermined Change Control Plan (PCCP) |
| Velmeni for Dentists (V4D) Endo-Perio | K252953 | May 11, 2026 | Assists dentists in the clinical detection of tooth anatomy, jaw anatomy, bone level and root canal treated teeth in digital bitewing, periapical and panoramic radiographs |
| VELMENI for DENTISTS (V4D) 3D | K254096 | July 23, 2026 | Assists in the clinical detection of anatomical structures (maxilla plus cranium, mandible, mandibular canal, temporomandibular joint, maxillary sinus, teeth, airway) in CBCT radiographs |
Each clearance says the software provides additional information and is not a replacement for a complete examination or the dentist’s clinical judgment; final diagnoses and treatment plans are the dentist’s responsibility. In plain terms, every mark VELMENI draws is a suggestion that the dentist confirms or rejects.
On 3D, the vendor’s site contradicts itself. A banner on the home page says “VELMENI 3D is now FDA cleared.” Yet the footer on all four saved pages says “The 3D features are available for research and investigation purposes only, and is undergoing FDA clearance,” and the 3D product page calls it an “upcoming 3D feature” for research only. According to the FDA record, K254096 was cleared on July 23, 2026, for detecting the anatomical structures listed above. Velmeni’s 3D page also lists treatment planning among the uses of the 3D views. The cleared indications cover detecting anatomical structures and leave final treatment plans to the dentist, and the 510(k) summary says the STL export is not intended for treatment planning. Ask Velmeni which 3D features you would get and under which clearance.
On privacy, the saved pages say nothing about HIPAA, BAAs or security certifications. Velmeni’s FDA summaries say the software is cloud hosted and stores user data, patient profiles and radiographs, and the Endo-Perio summary says Velmeni ran cybersecurity testing per FDA guidance. Ask for a BAA before you upload patient images.
Pricing
Pricing on request (checked October 21, 2026).
Who it’s for
VELMENI fits a practice that takes bitewings, periapicals and panoramics and also has a CBCT unit, and wants FDA-cleared AI marks on both from one web app. It may also appeal if you want the AI to label anatomy and bone levels, which the Endo-Perio clearance covers.
Look elsewhere, or ask more questions first, if you treat many patients under 15, since none of the clearances covers them. The same goes if you need a written list of supported PMS and imaging systems, published prices or a BAA before a sales call. The testimonials on the home page won’t help you judge it: three of the four quotes under “client stories” come from people listed with titles such as Chief Strategy Officer and Chief Dental Officer, and two of them, Maxine Feinberg and Alan Friedel, are listed at VELMENI Inc. as authors of the 2026 Science Progress study.
FAQ
Is VELMENI FDA cleared?
Yes. The FDA’s 510(k) database lists four clearances for Velmeni, Inc.: K240003 (August 30, 2024) and K250753 (September 2, 2025) for caries, restorations, fixed prostheses and implants on 2D radiographs, K252953 (May 11, 2026) for anatomy, bone level and root canal treated teeth, and K254096 (July 23, 2026) for anatomical structures on CBCT. All are for patients 15 years of age or older.
How much does VELMENI cost?
Pricing on request (checked October 21, 2026).
How accurate is VELMENI?
It depends on the finding. In a 2026 Science Progress study of 407 bitewings from 315 adult patients, the AI’s sensitivity was 0.972 for caries and 0.974 for restorations against radiologist consensus, but its agreement with the radiologists on caries was lower (kappa 0.454 to 0.508) than on restorations or prostheses. Three of that study’s authors are listed at VELMENI Inc. In Velmeni’s 2024 FDA reader study, 12 dentists (11 for the periapical result) scored higher on caries with the software on all three 2D image types.
Does VELMENI replace the dentist’s diagnosis?
No. Each FDA clearance says the software is not a replacement for a complete examination or the dentist’s clinical judgment, and that final diagnoses and treatment plans are the dentist’s responsibility. The vendor’s own footer says the same.
Does VELMENI work on CBCT scans?
Yes, for anatomy. The FDA cleared VELMENI for DENTISTS (V4D) 3D on July 23, 2026 (K254096) to assist in detecting the maxilla plus cranium, mandible, mandibular canal, TMJ, maxillary sinus, teeth and airway on CBCT radiographs. The vendor’s site footer still described the 3D features as research only on October 21, 2026, so confirm with Velmeni what is live.
Does VELMENI work with my PMS or imaging software?
Velmeni’s pages don’t say which systems it supports. Its FDA summaries describe VELMENI BRIDGE, which exchanges data with third-party patient management or imaging software, and list JPEG and PNG input for 2D and DICOM for CBCT. Ask Velmeni to confirm your PMS, viewer and sensors in writing.
How this review was put together
We didn’t use VELMENI ourselves. This review is built from four pages of Velmeni’s website (home, products, 2D and 3D), the FDA’s 510(k) and PMA databases and the four 510(k) decision documents, and a PubMed search for “Velmeni”. User reviews were not collected for this review. All sources were checked on October 21, 2026.
Sources
- VELMENI: home page, accessed October 21, 2026
- VELMENI: Products page, accessed October 21, 2026
- VELMENI for DENTISTS 2D product page, accessed October 21, 2026
- VELMENI for DENTISTS 3D product page, accessed October 21, 2026
- FDA 510(k) K240003, Velmeni for Dentists (V4D), accessed October 21, 2026
- FDA 510(k) K250753, VELMENI for DENTISTS (V4D), accessed October 21, 2026
- FDA 510(k) K252953, Velmeni for Dentists (V4D) Endo-Perio, accessed October 21, 2026
- FDA 510(k) K254096, VELMENI for DENTISTS (V4D) 3D, accessed October 21, 2026
- openFDA device 510(k) and PMA databases (search of Velmeni), accessed October 21, 2026
- Deep learning-based segmentation of caries, implants, fixed prosthesis, and restorations on bitewing radiographs: A retrospective study, Science Progress (2026), accessed October 21, 2026
- PubMed search for “Velmeni”, accessed October 21, 2026
