- What it does: Velmeni sells VELMENI for DENTISTS (V4D), AI that marks findings on 2D dental x-rays, plus a 3D version for CBCT. Its 2D clearances cover caries, restorations, crowns and bridges, implants, bone level and root-canal-treated teeth on bitewing, periapical and panoramic images for patients 15 and older. The CBCT clearance covers anatomy only. The company also lists voice perio charting and claims tools.
- Regulatory: 4 FDA 510(k) clearances (K254096, K252953, K250753, K240003)
- Pricing: Not published (Quote via demo request)
- Best fit: solo, group
Velmeni is a reasonable shortlist candidate for a general practice that wants one AI read across bitewings, periapicals and panoramics, since all three image types are in its 2D clearances. Its finding list is narrower than Pearl's or VideaHealth's on paper: no calculus or periapical radiolucency detection is cleared. Ask for pricing and confirm your PMS and imaging software integration before a demo turns into a contract.
Velmeni vs alternatives
Other imaging & diagnostics tools we track: Overjet (quote only, 12 FDA clearances), Pearl (quote only, 8 FDA clearances), Dentsply Sirona DS Core (quote only, 4 FDA clearances), VideaHealth (quote only, 4 FDA clearances).
Is Velmeni FDA cleared?
Yes. Velmeni holds 4 FDA 510(k) clearances: K254096 (Jul 23, 2026) for vELMENI for DENTISTS (V4D) 3D: concurrent-read detection of anatomical structures (jaws, mandibular canal, TMJ, maxillary sinus, teeth, airway) on CBCT scans of permanent teeth, patients 15 and older.; K252953 (May 11, 2026) for vELMENI for DENTISTS (V4D) Endo-Perio: concurrent-read detection of tooth anatomy (enamel, dentine, pulp, root), jaw anatomy (mental foramen, inferior alveolar canal, maxillary sinus), bone level (CEJ and crestal bone) and root-canal-treated teeth on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older.; K250753 (Sep 2, 2025) for vELMENI for DENTISTS (V4D), updated with a predetermined change control plan: concurrent-read detection of caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older.; K240003 (Aug 30, 2024) for vELMENI for DENTISTS (V4D): concurrent-read detection of caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older.. Features outside those indications are not covered by the clearance.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K254096 | VELMENI for DENTISTS (V4D) 3D | Jul 23, 2026 | VELMENI for DENTISTS (V4D) 3D: concurrent-read detection of anatomical structures (jaws, mandibular canal, TMJ, maxillary sinus, teeth, airway) on CBCT scans of permanent teeth, patients 15 and older. |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | May 11, 2026 | VELMENI for DENTISTS (V4D) Endo-Perio: concurrent-read detection of tooth anatomy (enamel, dentine, pulp, root), jaw anatomy (mental foramen, inferior alveolar canal, maxillary sinus), bone level (CEJ and crestal bone) and root-canal-treated teeth on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older. |
| K250753 | VELMENI for DENTISTS (V4D) | Sep 2, 2025 | VELMENI for DENTISTS (V4D), updated with a predetermined change control plan: concurrent-read detection of caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older. |
| K240003 | Velmeni for Dentists (V4D) | Aug 30, 2024 | VELMENI for DENTISTS (V4D): concurrent-read detection of caries, fillings/restorations, fixed prostheses and implants on bitewing, periapical and panoramic radiographs, permanent teeth, patients 15 and older. |
What Velmeni does
Imaging modalities: bitewing, periapical, panoramic, CBCT.
- V4D 2D: concurrent-read detection of caries, fillings and restorations, fixed prostheses and implants on bitewing, periapical and panoramic x-rays (FDA-cleared)
- V4D Endo-Perio: tooth and jaw anatomy, bone level and root-canal-treated teeth on the same 2D image types (FDA-cleared, May 2026)
- V4D 3D: labels jaws, mandibular canal, TMJ, maxillary sinus, teeth and airway on CBCT (FDA-cleared, July 2026)
- Also listed on velmeni.ai: VELMENI Voice perio charting, VELMENI for Claims, 3D Verify and EasyRiter Cone Beam (not covered by the imaging clearances)
How much does Velmeni cost?
Velmeni does not publish pricing; it is quoted by sales (Quote via demo request). velmeni.ai has no public pricing page; plans are quoted after a demo.
- 2D clearances include panoramic x-rays as well as bitewings and periapicals
- One of the few vendors with a CBCT clearance (K254096, anatomy only)
- The 2025 clearance (K250753) includes a predetermined change control plan, which lets Velmeni update its models within limits the FDA agreed in advance
- Cleared for permanent teeth in patients 15 and older; no pediatric clearance
- The CBCT clearance labels anatomy; it does not cover detecting disease on CBCT
- No public pricing, and no integration list we could verify
- The velmeni.ai footer still says its 3D features are for research use and undergoing FDA clearance, though K254096 was cleared in July 2026
What we have not verified
We have not used Velmeni in a practice. The company's adoption and performance figures on velmeni.ai (offices, countries, detection and revenue lift) are its own claims and are not verified here. We could not confirm which practice management systems it connects to.
Sources
- FDA 510(k) K254096 (VELMENI for DENTISTS (V4D) 3D)
- FDA 510(k) K252953 (Velmeni for Dentists (V4D) Endo-Perio)
- FDA 510(k) K250753 (VELMENI for DENTISTS (V4D))
- FDA 510(k) K240003 (Velmeni for Dentists (V4D))
- Velmeni website
- Velmeni: About (leadership, offices)
- FDA: Artificial Intelligence-Enabled Medical Devices list