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e-CFR data is current as of August 4, 2020

Title 21Chapter ISubchapter HPart 872Subpart B → §872.1800


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices


§872.1800   Extraoral source x-ray system.

(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.

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