FDA Product Code EHD: Unit, X-ray, Extraoral With Timer
Under FDA product code EHD, extraoral dental X-ray units with timers are cleared for panoramic and cephalometric radiography in dental practice.
These systems capture wide-field dental images of the jaws, teeth, and craniofacial structures from an external X-ray source positioned outside the mouth. Integrated timers control radiation exposure duration for consistent, reproducible image quality.
EHD devices are Class II medical devices, regulated under 21 CFR 872.1800 and reviewed by the FDA Radiology panel.
Leading manufacturers include Lucas Lifecare, Picopack Co., Ltd. and Raypia Co., Ltd..
FDA 510(k) Cleared Unit, X-ray, Extraoral With Timer Devices (Product Code EHD)
About Product Code EHD - Regulatory Context
510(k) Submission Activity
189 total 510(k) submissions under product code EHD since 1977, with 189 receiving FDA clearance (average review time: 97 days).
Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 17 in the prior period.
FDA Review Time
FDA review times for EHD submissions have been consistent, averaging 107 days recently vs 96 days historically.
EHD devices are reviewed by the Radiology panel. Browse all Radiology devices →