FDA-cleared dental AI companies
20 companies hold 55 FDA 510(k) clearances for dental AI software. Below is every one, with what it is cleared to do and a link to the FDA filing. We build the list from the FDA's 510(k) database and its AI-enabled device list, and re-check it every Monday.
- 55 clearances from 20 companies; 14 so far in 2026.
- Most clearances: Overjet (12), Pearl (8), Dentsply Sirona (4).
- By image type: 40 cover 2D x-rays, 14 cover CBCT, 9 cover intraoral scans, treatment design or navigation.
- Most clearances cover one task on one image type (for example, caries on bitewings in adults). Check the scope before assuming a feature is cleared.
Newest clearances
- Sep 25, 2026Align 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, 2026Dentsply 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, 2026Overjet · 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
- Jul 15, 2026Better 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, 2026Velmeni · 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.
Companies
| Company | 510(k)s | Image types | Latest |
|---|---|---|---|
| Overjet | 12 | 2D x-rays, CBCT | Aug 6, 2026 |
| Pearl | 8 | 2D x-rays, CBCT | Nov 14, 2025 |
| Dentsply Sirona | 4 | 2D x-rays, CBCT, Scans, design & navigation | Aug 21, 2026 |
| Velmeni | 4 | 2D x-rays, CBCT | Jul 23, 2026 |
| VideaHealth | 4 | 2D x-rays | Sep 19, 2025 |
| Nobel Biocare | 3 | 2D x-rays | Nov 17, 2025 |
| Better Diagnostics AI | 2 | 2D x-rays | Jul 15, 2026 |
| Relu | 2 | CBCT, Scans, design & navigation | Apr 10, 2026 |
| Orca Dental AI | 2 | 2D x-rays, CBCT | Mar 5, 2026 |
| Diagnocat | 2 | CBCT | Jan 15, 2026 |
| Ewoosoft | 2 | 2D x-rays, CBCT | May 23, 2025 |
| Denti.AI | 2 | 2D x-rays | Oct 6, 2023 |
| Align Technology | 1 | Scans, design & navigation | Sep 25, 2026 |
| ChohoTech | 1 | Scans, design & navigation | May 8, 2026 |
| 3Shape | 1 | Scans, design & navigation | Apr 10, 2026 |
| Bench7 | 1 | 2D x-rays | Nov 7, 2025 |
| Audax | 1 | 2D x-rays | May 30, 2025 |
| Cube Click | 1 | 2D x-rays | May 14, 2025 |
| Ray | 1 | Scans, design & navigation | May 16, 2024 |
| X-Nav Technologies | 1 | CBCT, Scans, design & navigation | Feb 21, 2024 |
By year
2026 is year to date.
All clearances
| Decision | 510(k) | Company / device | Cleared for | Images |
|---|---|---|---|---|
| Sep 25, 2026 | K262196 | Align Technology Invisalign System | 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. | intraoral scan |
| Aug 21, 2026 | K262127 | Dentsply Sirona DS Core CBCT Anatomy | Segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning (updated clearance). | CBCT, intraoral scan |
| Aug 6, 2026 | K261059 | Overjet Overjet Multi-Image Caries and Charting Assist | 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. | bitewing, periapical, panoramic |
| Jul 23, 2026 | K254096 | Velmeni VELMENI for DENTISTS (V4D) 3D | 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. | CBCT |
| Jul 15, 2026 | K260851 | Better Diagnostics AI Better Diagnostics Dental Assist (BDDA) Version 1.0 | Measures mesial and distal bone levels and marks suspected findings (marginal discrepancy, calculus, periapical radiolucency and more) on bitewing and periapical radiographs. | bitewing, periapical |
| May 11, 2026 | K252953 | Velmeni Velmeni for Dentists (V4D) Endo-Perio | 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. | bitewing, periapical, panoramic |
| May 8, 2026 | K260419 | ChohoTech LingOral Dental Design System | LingOral Dental Design System: treatment-planning simulations and design of crowns, bridges, veneers, inlays/onlays and clear aligners from 3D mesh (intraoral scan) data. | intraoral scan |
| Apr 23, 2026 | K260785 | Dentsply Sirona DS Core CBCT Anatomy | Cloud AI service that segments anatomy on CBCT scans and intraoral (digital impression) scans for diagnostic review and treatment planning. | CBCT, intraoral scan |
| Apr 10, 2026 | K260082 | 3Shape TRIOS Dx (R1) | TRIOS Dx: aid in diagnosing and tracking caries, tooth wear, gingival recession and plaque from TRIOS intraoral scans. | intraoral scan |
| Apr 10, 2026 | K253930 | Overjet Overjet Iris Intelligent Imaging System | Web-based image management (PACS): acquires, stores, displays and shares dental images from intraoral sensors and panoramic units. | bitewing, periapical, panoramic |
| Apr 10, 2026 | K252708 | Relu Relu Cloud | Management and analysis of oral and maxillofacial images to support diagnosis and treatment planning; provides design input for dental solutions. | CBCT, intraoral scan |
| Mar 5, 2026 | K252538 | Orca Dental AI CEPHX3D | CephX3D: analysis of dental and craniomaxillofacial images (including 3D) to support diagnosis and treatment planning, for patients 12 and older. | CBCT, cephalometric |
| Jan 15, 2026 | K252934 | Diagnocat Diagnocat | Concurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older. | CBCT |
| Jan 7, 2026 | K253009 | Dentsply Sirona DS Core Detect | DS Core Detect: concurrent-read detection of permanent teeth that may have periapical radiolucency on CBCT scans already taken for other reasons, adults 22 and older. | CBCT |
| Dec 5, 2025 | K251514 | Overjet Overjet CBCT Assist | AI segmentation, measurements and 2D/3D visualization of dental and craniomaxillofacial CBCT scans. | CBCT |
| Nov 17, 2025 | K252086 | Nobel Biocare DTX Studio Assist | DTX Studio Assist: SDK for imaging software that measures alveolar bone levels, segments restorations and anatomy, and flags caries, calculus, periapical radiolucency, root canal filling deficiency and restoration-margin discrepancy on bitewing and periapical radiographs, permanent teeth, patients 15 and older. | bitewing, periapical |
| Nov 14, 2025 | K250525 | Pearl Second Opinion® Panoramic | Marks suspected caries, periapical radiolucency and impacted third molars on panoramic radiographs, patients 16 and older. | panoramic |
| Nov 7, 2025 | K250264 | Bench7 SugarBug (1.x) | SugarBug: concurrent-read detection and segmentation of caries on bitewing radiographs, patients 18 and older. | bitewing |
| Sep 19, 2025 | K251002 | VideaHealth Videa Dental AI | Videa Dental AI: computer-aided detection on bitewing, periapical and panoramic radiographs, patients 3 and older. Flags suspected caries, attrition, broken teeth, restorative imperfections, pulp stones, dens invaginatus, periapical radiolucency, widened periodontal ligament, furcation and calculus, plus past treatments (crowns, fillings, bridges, root canals, implants) and normal anatomy. | bitewing, periapical, panoramic |
| Sep 9, 2025 | K251072 | Diagnocat Segmentron Viewer | Segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only. | CBCT |
| Sep 2, 2025 | K250753 | Velmeni VELMENI for DENTISTS (V4D) | 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. | bitewing, periapical, panoramic |
| Aug 12, 2025 | K250755 | Dentsply Sirona DS Core Diagnosis | DS Core Diagnosis: cloud viewer for reviewing and analyzing dental images and other patient media to support diagnosis. Its Panoramic Curve Proposal feature is for patients 12 and older with permanent dentition. | bitewing, periapical, panoramic |
| Jun 12, 2025 | K243234 | Pearl Second Opinion® CS | Second Opinion CS: detection and segmentation of caries on periapical radiographs, permanent teeth, patients 12 and older (second reader). | periapical |
| May 30, 2025 | K243005 | Audax AudaxCeph Cephalogram Analysis Software | AudaxCeph: cephalogram landmarking, tracing and measurement for orthodontic treatment planning. FDA lists it as AI-enabled. | cephalometric |
| May 23, 2025 | K250005 | Ewoosoft Clever One | Clever One: dental imaging software for viewing and analyzing CT, panoramic, cephalometric and intraoral images in 2D and 3D. FDA lists it as AI-enabled; the public summary does not say which feature uses AI. | CBCT, panoramic, cephalometric, bitewing, periapical |
| May 23, 2025 | K243989 | Pearl Second Opinion® 3D | Second Opinion 3D: marks anatomy on CBCT (dentition, maxilla, mandible, inferior alveolar canal, sinus, airway). | CBCT |
| May 14, 2025 | K242437 | Cube Click Smile Dx® | Smile Dx: detection and segmentation of caries, periapical radiolucency, restorations and anatomy, plus mesial and distal bone-level measurement, on bitewing and periapical radiographs of permanent teeth. | bitewing, periapical |
| May 9, 2025 | K243230 | Pearl Second Opinion® BLE | Second Opinion BLE: bone-level measurements on bitewing and periapical radiographs, patients 12 and older. | bitewing, periapical |
| May 5, 2025 | K243893 | Pearl Second Opinion® Pediatric | Second Opinion Pediatric: caries detection on bitewing and periapical radiographs, patients 4 and older (primary or mixed dentition). | bitewing, periapical |
| Apr 11, 2025 | K242600 | Pearl Second Opinion Periapical Radiolucency Contours | Periapical radiolucency detection with outlined regions on periapical radiographs, permanent teeth, patients 12 and older (second reader). | periapical |
| Mar 11, 2025 | K241725 | Better Diagnostics AI Better Diagnostics Caries Assist (BDCA) Version 1.0 | Concurrent-read caries detection on bitewing and periapical radiographs, patients 18 and older. | bitewing, periapical |
| Jan 16, 2025 | K242522 | Pearl Second Opinion CC | Second Opinion CC: caries detection with outlined regions on bitewing and periapical radiographs, patients 19 and older (second reader). | bitewing, periapical |
| Sep 9, 2024 | K241681 | Overjet Overjet Image Enhancement Assist | Image Enhancement Assist: AI noise reduction and contrast/sharpness enhancement of dental radiographs in the Overjet platform. | bitewing, periapical |
| Aug 30, 2024 | K240003 | Velmeni Velmeni for Dentists (V4D) | 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. | bitewing, periapical, panoramic |
| Aug 27, 2024 | K241684 | Overjet Overjet Charting Assist | Charting Assist (updated): detects tooth anatomy, tooth numbers and existing restorations (implants, crowns, root canals, fillings) to assist charting. | bitewing, periapical, panoramic |
| Jun 13, 2024 | K233925 | Relu Relu Creator | Relu Creator: management and analysis of dental and craniomaxillofacial images; provides design input for dental solutions. | CBCT, intraoral scan |
| May 16, 2024 | K233625 | Ray RAYDENT SW | RAYDENT SW: treatment-planning simulations and design of crowns, bridges, veneers, inlays/onlays and clear aligners from 3D mesh (intraoral scan) data. The summary marks it AI/ML-enabled. | intraoral scan |
| Mar 4, 2024 | K233738 | Overjet Overjet Caries Assist-Pediatric | Caries Assist-Pediatric: concurrent-read caries detection and segmentation on bitewing and periapical radiographs in children. | bitewing, periapical |
| Feb 23, 2024 | K233590 | Overjet Overjet Charting Assist | Charting Assist: detects tooth anatomy, tooth numbers and existing restorations to assist dental charting. | bitewing, periapical, panoramic |
| Feb 21, 2024 | K232148 | X-Nav Technologies X-Guide Surgical Navigation System | X-Guide surgical navigation for dental implant and endodontic access procedures; this clearance added machine-learning segmentation of anatomy on maxillofacial CT and intraoral scans. | CBCT, intraoral scan |
| Jan 31, 2024 | K231396 | Orca Dental AI CEPHX- Cephalometric Analysis Software | CephX: cephalometric analysis, simulation, profilogram and VTO for orthodontic treatment, patients 14 and older. | cephalometric |
| Dec 15, 2023 | K232384 | VideaHealth Videa Dental Assist | Videa Dental Assist: detects caries and other findings on bitewing, periapical and panoramic radiographs, patients 3 and older. | bitewing, periapical, panoramic |
| Dec 8, 2023 | K231898 | Nobel Biocare DTX Studio Clinic (4.0) | DTX Studio Clinic 4.0: computer-aided detection of six dental findings on bitewing and periapical radiographs (described in the K252086 summary, which uses it as predicate; this filing's own PDF is image-only). | bitewing, periapical |
| Oct 6, 2023 | K230144 | Denti.AI Denti.AI Detect | Denti.AI Detect: second-reader detection of caries and periapical radiolucency on intraoral and extraoral 2D radiographs. | bitewing, periapical, panoramic |
| Sep 21, 2023 | K231678 | Overjet Overjet Periapical Radiolucency Assist | Periapical Radiolucency Assist: concurrent-read detection of periapical radiolucencies on periapical radiographs, permanent teeth. | periapical |
| Jul 14, 2023 | K231757 | Ewoosoft Ez3D-i /E3 | Ez3D-i: dental imaging software for viewing CT, panoramic, cephalometric and intraoral images with 3D visualization and 2D analysis. FDA lists it as AI-enabled; the public summary does not say which feature uses AI. | CBCT, panoramic, cephalometric, bitewing, periapical |
| Mar 28, 2023 | K221921 | Nobel Biocare DTX Studio Clinic 3.0 | DTX Studio Clinic 3.0: concurrent-read detection of caries, calculus, periapical radiolucency, root canal filling deficiency, restoration-margin discrepancy and bone loss on bitewing and periapical radiographs, patients 15 and older. | bitewing, periapical |
| Mar 27, 2023 | K222746 | Overjet Overjet Caries Assist | Caries Assist (expanded): concurrent-read caries detection and segmentation on bitewing and periapical radiographs. | bitewing, periapical |
| Feb 6, 2023 | K223296 | VideaHealth Videa Perio Assist | Videa Perio Assist: mesial and distal bone-level measurements on bitewing and periapical radiographs. | bitewing, periapical |
| Dec 16, 2022 | K220928 | Overjet Overjet Calculus Assist | Calculus Assist: concurrent-read detection of interproximal calculus on bitewing and periapical radiographs. | bitewing, periapical |
| Nov 22, 2022 | K222054 | Denti.AI Denti.AI Auto-Chart | Denti.AI Auto-Chart: detects dental structures and restorations on intraoral and extraoral 2D radiographs to produce charting data. | bitewing, periapical, panoramic |
| May 10, 2022 | K212519 | Overjet Overjet Caries Assist | Caries Assist: concurrent-read detection of caries on bitewing radiographs. | bitewing |
| Apr 21, 2022 | K213795 | VideaHealth Videa Caries Assist | Videa Caries Assist: detection and segmentation of carious lesions on bitewing radiographs, adults 22 and older. | bitewing |
| Mar 4, 2022 | K210365 | Pearl Second Opinion | Second Opinion: detection of caries, calculus, periapical radiolucency and other findings on bitewing and periapical radiographs. | bitewing, periapical |
| May 19, 2021 | K210187 | Overjet Overjet Dental Assist | Dental Assist: automated measurement of alveolar bone level on bitewing and periapical radiographs. | bitewing, periapical |
What counts: a 510(k) clearance for software used in dentistry that is on the FDA's AI-enabled device list or whose FDA summary describes AI or machine learning. Scope summaries paraphrase each clearance's Indications for Use; the linked FDA document is authoritative. Left out: general radiology tools that only list maxillofacial among many uses (such as Axial3D Insight), De Novo grants (DentalMonitoring) and PMA approvals (the 1998 Logicon Caries Detector). Missing a clearance? Tell us.
The full table as CSV or JSON: 510(k) number, company, applicant, device, decision date, product code, image types, findings, cleared use and FDA links. 55 rows, verified Oct 26, 2026.
Free to reuse under CC BY 4.0. Credit "AI Dental Tools" and link to this page.
Frequently asked questions
Which dental AI companies have FDA clearance?
As of Oct 26, 2026, 20 companies hold FDA 510(k) clearances for dental AI: Overjet (12), Pearl (8), Dentsply Sirona (4), Velmeni (4), VideaHealth (4), Nobel Biocare (3), Better Diagnostics AI (2), Relu (2), Orca Dental AI (2), Diagnocat (2), Ewoosoft (2), Denti.AI (2), Align Technology (1), ChohoTech (1), 3Shape (1), Bench7 (1), Audax (1), Cube Click (1), Ray (1), X-Nav Technologies (1).
How many dental AI products are FDA cleared?
We count 55 FDA 510(k) clearances for dental AI software as of Oct 26, 2026: 40 cover 2D x-rays (bitewing, periapical, panoramic or cephalometric), 14 cover CBCT and 9 cover intraoral scans, treatment design or surgical navigation. Some cover more than one.
What does FDA clearance mean for dental AI?
A 510(k) clearance means the FDA found the device substantially equivalent to a legally marketed device for specific indications, such as detecting caries on bitewing radiographs in adults. It is not an endorsement, and it only covers the indications in the decision; features outside them are not cleared.
Which dental AI is cleared for CBCT?
9 companies hold CBCT clearances: Dentsply Sirona (K262127, K260785, K253009); Velmeni (K254096); Relu (K252708, K233925); Orca Dental AI (K252538); Diagnocat (K252934, K251072); Overjet (K251514); Ewoosoft (K250005, K231757); Pearl (K243989); X-Nav Technologies (K232148). Only Diagnocat (K252934) and Dentsply Sirona DS Core Detect (K253009) cover flagging a disease finding; the rest segment anatomy or support viewing and planning.
Which dental AI is cleared for children?
Clearances that cover children: Overjet Multi-Image Caries and Charting Assist (K261059); VideaHealth Videa Dental AI (K251002); Pearl Second Opinion® Pediatric (K243893); Overjet Caries Assist-Pediatric (K233738); VideaHealth Videa Dental Assist (K232384). Most other clearances are limited to permanent teeth or adults.
Can I download this list?
Yes. The full table is available as CSV and JSON at https://aidentaltools.com/data/dental-ai-fda-clearances.csv and https://aidentaltools.com/data/dental-ai-fda-clearances.json under a CC BY 4.0 license. Credit AI Dental Tools and link to this page.