EHA · Aligner, Beam, X-Ray
Dental · 21 CFR 872.1820 · Class 1
Overview
| Product Code | EHA |
|---|---|
| Device Name | Aligner, Beam, X-Ray |
| Regulation | 21 CFR 872.1820 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891186 | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT | Benn Research , Ltd. | Apr 12, 1989 | SESE |
Top Applicants
- Benn Research , Ltd. — 1 clearance
