eCFR Reference Browser

---

title: "21 CFR §872.1800"

source: "https://www.ecfr.gov/current/title-21/section-872.1800"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "872"

part_subject: "DENTAL DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "872.1800"

section_subject: "Extraoral source x-ray system."

cfr_reference: "21 CFR 872.1800"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§872.1800 - Extraoral source x-ray system.