What dental AI actually does, what the FDA actually cleared, and what it costs.
A reference for dentists, practice managers, and DSO operators evaluating AI. Every regulatory claim links to its 510(k) filing.
Registry last verified Oct 26, 2026 against the FDA 510(k) database.
Recent FDA clearances
All 20 FDA-cleared dental AI companies →| Decision | Product | 510(k) | Cleared for |
|---|---|---|---|
| Sep 25, 2026 | Align Technology Invisalign System | K262196 | Invisalign System: adds an optional AI-enabled prediction service to Invisalign's 3D treatment-planning software to optimize aligner activation design; the doctor reviews and approves each plan. |
| Aug 21, 2026 | Dentsply Sirona DS Core CBCT Anatomy | K262127 | Segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance). |
| Aug 6, 2026 | Overjet Overjet Multi-Image Caries and Charting Assist | K261059 | Multi-Image Caries and Charting Assist: reads all of a patient's radiographs together. Detects and outlines caries (incipient, non-incipient, secondary) on bitewings and periapicals, and tooth anatomy, tooth numbers and past restorations on bitewing, periapical and panoramic radiographs, patients 4 and older. |
| Jul 23, 2026 | Velmeni VELMENI for DENTISTS (V4D) 3D | K254096 | 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. |
| Jul 15, 2026 | Better Diagnostics AI Better Diagnostics Dental Assist (BDDA) Version 1.0 | K260851 | Measures mesial and distal bone levels and marks suspected findings (marginal discrepancy, calculus, periapical radiolucency and more) on bitewing and periapical radiographs. |
| May 11, 2026 | Velmeni Velmeni for Dentists (V4D) Endo-Perio | K252953 | 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. |
FDA-cleared imaging AI
All 22 tools →
Overjet
FDA-cleared AI for dental x-ray analysis with quantitative bone and caries measurements.
Pearl
AI-powered dental imaging platform with pathology detection across radiograph types.
Dentsply Sirona DS Core
AI built into Dentsply Sirona's cloud platform: CBCT periapical detection, diagnosis support and CBCT/scan anatomy
Velmeni
FDA-cleared AI for caries, restorations and bone level on 2D x-rays, plus CBCT anatomy
VideaHealth
AI dental x-ray analysis trained on the largest proprietary dental radiograph dataset.
Better Diagnostics
FDA-cleared caries detection and bone-level measurement on bitewings and periapicals
Denti.AI
FDA-cleared radiograph detection and auto-charting, plus an AI scribe and voice perio charting
Diagnocat
AI-powered CBCT and panoramic radiograph analysis with automated segmentation and reporting.
Orca Dental AI
AI cephalometric analysis and CBCT segmentation for orthodontic and dental imaging workflows.
Relu
AI segmentation of CBCT and intraoral scans for treatment planning and design
Latest
- How to Use AI for Dental Insurance Narratives: A Prompt Library for Common Procedures
Dental insurance narrative templates and examples for SRP (D4341), crowns, buildups, implants and ortho, plus 8 AI prompts with unedited outputs.
prompts - Best Dental Practice Management Software in 2026: 9 Systems Compared
Dentrix, Open Dental, Eaglesoft, Dentrix Ascend, Curve, Denticon, CareStack, Oryx and tab32 compared on hosting, published pricing, built-in AI and fit.
listicle - 15 ChatGPT Prompts for Dental Practice Marketing: Social Posts, Website Copy, and Google Business Profile Descriptions
15 ChatGPT prompts for dentists: social posts, website pages, Google Business Profile text and newsletters, each with an unedited example output.
prompts - Dental AI X-Ray Software Pricing in 2026: Published Prices and How Vendors Charge
Better Diagnostics is $149 a month in Open Dental, Denti.AI $399 ($333 yearly), Diagnocat from €499 a year. Overjet, Pearl and VideaHealth quote. Sources.
pricing - Open Dental Pricing in 2026: Every Fee, Explained
Open Dental costs $199 per location per month for the first year, then $149. Every published fee: providers, Cloud, eServices, texting, AI x-ray and eRx.
pricing - Overjet vs. Pearl: What the FDA 510(k) Clearance Letters Actually Say (A Side-by-Side Reading)
Overjet and Pearl compared from their FDA 510(k) clearance letters: what each is cleared to detect, CBCT support, PMS integrations and pricing model.
comparison - What Is CBCT in Dentistry? Cone Beam CT Scans, Dose and AI
CBCT (cone beam CT) is a dental x-ray scanner that makes a 3D image of teeth, jaws and nerves. Uses, radiation dose, ADA guidance and FDA-cleared AI.
explainer - Using AI to Write Dental Office SOPs and Training Materials
How to use ChatGPT and Claude to draft dental office SOPs, sterilization checklists and onboarding materials, with exact prompts and what to fix first.
guide
Sections
How we work
Methodology →Primary sources first
Regulatory claims come from FDA 510(k) decision letters, not vendor marketing. Every clearance links to its filing.
Scope, not slogans
We state exactly what each clearance covers, and flag features that fall outside it.
Paid content is labelled
Sponsored placements and paid links are marked as sponsored. We correct errors in public and date every change.
Dated and re-verified
Each profile shows when it was last checked. Pricing and integrations are re-verified on a schedule.