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 Planmeca Oy, VATECH Co., Ltd. and Trophy Radiologie.