21 CFR §872.1810
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.