21 CFR 872.1820 — Aligner, Beam, X-Ray
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1820
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EHA | Aligner, Beam, X-Ray | 1 | 1 |
