EAH · Cone, Radiographic, Lead-Lined
Dental · 21 CFR 872.1850 · Class 1
Overview
| Product Code | EAH |
|---|---|
| Device Name | Cone, Radiographic, Lead-Lined |
| Regulation | 21 CFR 872.1850 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840275 | CEHPALOMETRIC HEAD POSITIONER | Gary E. Hall, Dds | Mar 16, 1984 | SESE |
| K771748 | INTRA ORAL X-RAY CONES | General Electric Co. | Sep 28, 1977 | SESE |
Top Applicants
- Gary E. Hall, Dds — 1 clearance
- General Electric Co. — 1 clearance
