GroundRules
21 CFR 872.1820: Dental x-ray exposure alignment device.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 872—DENTAL DEVICES
- Subpart B—Diagnostic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON