21 CFR 872.1850 — Cone, Radiographic, Lead-Lined
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1850
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EAH | Cone, Radiographic, Lead-Lined | 1 | 2 |
