Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 872 - DENTAL DEVICES
/ Subpart B - Diagnostic Devices / § 872.1820 Dental x-ray exposure alignment device.
§ 872.1820 Dental x-ray exposure alignment device.
(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x-ray beam.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.