21 C.F.R. § 872.1800
Extraoral source x-ray system.
Cite as 21 C.F.R. § 872.1800 (2026)
(a)
Identification.
An extraoral source x-ray system is an AC-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 outside the mouth. This generic type of device may include patient and equipment supports and component parts.
(b)
Classification.
Class II.