Code of Federal Regulations Title 21. Food and Drugs § 21.872.1810 Intraoral source x-ray system

(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.