Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1850](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1850) → EAH — Cone, Radiographic, Lead-Lined

# EAH · Cone, Radiographic, Lead-Lined

_Dental · 21 CFR 872.1850 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAH

## Overview

- **Product Code:** EAH
- **Device Name:** Cone, Radiographic, Lead-Lined
- **Regulation:** [21 CFR 872.1850](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1850)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAH/K840275.md) | CEHPALOMETRIC HEAD POSITIONER | Gary E. Hall, Dds | Mar 16, 1984 | SESE |
| [K771748](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAH/K771748.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAH](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAH)

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