DentalAtlas
FDA DEVICE RECORDS

FDA-cleared dental AI tools

Every device record we matched in the official FDA database, with the 510(k) number and decision date. Each device is listed separately, because one vendor can hold several clearances.

Better Diagnostics AIBetter Diagnostics Caries Assist (BDCA) Version 1.0
K2417252025-03-11
FDA source →
Better Diagnostics AIBetter Diagnostics Dental Assist (BDDA) Version 1.0
K2608512026-07-15
FDA source →
DentalMonitoringDentalMonitoring
DEN2300352024-05-17
FDA source →
Denti.AIDenti.AI Detect
K2301442023-10-06
FDA source →
DiagnocatDiagnocat
K2529342026-01-15
FDA source →
DS Core DetectDS Core Detect
K2530092026-01-07
FDA source →
OverjetOverjet Dental Assist
K2101872021-05-19
FDA source →
OverjetOverjet Caries Assist
K2125192022-05-10
FDA source →
OverjetOverjet Calculus Assist
K2209282022-12-16
FDA source →
OverjetOverjet Caries Assist
K2227462023-03-27
FDA source →
OverjetOverjet Periapical Radiolucency Assist
K2316782023-09-21
FDA source →
OverjetOverjet Charting Assist
K2335902024-02-23
FDA source →
OverjetOverjet Caries Assist-Pediatric
K2337382024-03-04
FDA source →
OverjetOverjet Charting Assist
K2416842024-08-27
FDA source →
OverjetOverjet Image Enhancement Assist
K2416812024-09-09
FDA source →
OverjetOverjet CBCT Assist
K2515142025-12-05
FDA source →
OverjetOverjet Iris Intelligent Imaging System
K2539302026-04-10
FDA source →
OverjetOverjet Multi-Image Caries and Charting Assist
K2610592026-08-06
FDA source →
PearlSecond Opinion
K2103652022-03-04
FDA source →
PearlSecond Opinion CC
K2425222025-01-16
FDA source →
PearlSecond Opinion Periapical Radiolucency Contours
K2426002025-04-11
FDA source →
PearlSecond Opinion Pediatric
K2438932025-05-05
FDA source →
PearlSecond Opinion BLE
K2432302025-05-09
FDA source →
PearlSecond Opinion 3D
K2439892025-05-23
FDA source →
PearlSecond Opinion CS
K2432342025-06-12
FDA source →
PearlSecond Opinion Panoramic
K2505252025-11-14
FDA source →
VelmeniVelmeni for Dentists (V4D)
K2400032024-08-30
FDA source →
VelmeniVELMENI for DENTISTS (V4D)
K2507532025-09-02
FDA source →
VelmeniVelmeni for Dentists (V4D) Endo-Perio
K2529532026-05-11
FDA source →
VideaHealthVidea Caries Assist
K2137952022-04-21
FDA source →
VideaHealthVidea Perio Assist
K2232962023-02-06
FDA source →
VideaHealthVidea Dental Assist
K2323842023-12-15
FDA source →
VideaHealthVidea Dental AI
K2510022025-09-19
FDA source →