Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1820](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1820) → EHA — Aligner, Beam, X-Ray

# EHA · Aligner, Beam, X-Ray

_Dental · 21 CFR 872.1820 · Class 1_

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

## Overview

- **Product Code:** EHA
- **Device Name:** Aligner, Beam, X-Ray
- **Regulation:** [21 CFR 872.1820](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1820)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHA/K891186.md) | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT | Benn Research , Ltd. | Apr 12, 1989 | SESE |

## Top Applicants

- Benn Research , Ltd. — 1 clearance

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

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