e-CFR data is current as of February 24, 2021 |
Title 21 → Chapter I → Subchapter H → Part 872 → Subpart B → §872.1810 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
(a) Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.
(b) Classification. Class II.