Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1840](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1840) → EHB — Collimator, X-Ray

# EHB · Collimator, X-Ray

_Dental · 21 CFR 872.1840 · Class 1_

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

## Overview

- **Product Code:** EHB
- **Device Name:** Collimator, X-Ray
- **Regulation:** [21 CFR 872.1840](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1840)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K921355](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB/K921355.md) | WINGMASTER | Innovators, Inc. | Sep 25, 1992 | SESE |
| [K903012](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB/K903012.md) | AUDIOPRAT ENDOSCOPE | S.C.D.P.I. of Florida, Inc. | Oct 9, 1990 | SESE |
| [K834606](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB/K834606.md) | X-RAY COLLIMATOR X-CJD | Knochen Dental Laboratory | Feb 21, 1984 | SESE |
| [K833558](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB/K833558.md) | X-RAY SHIELD | Moyco Industries, Inc. | Jan 13, 1984 | SESE |
| [K781675](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB/K781675.md) | X-RAY COLLIMATOR | General X-Ray, Inc. | Dec 4, 1978 | SESE |

## Top Applicants

- General X-Ray, Inc. — 1 clearance
- Innovators, Inc. — 1 clearance
- Knochen Dental Laboratory — 1 clearance
- Moyco Industries, Inc. — 1 clearance
- S.C.D.P.I. of Florida, Inc. — 1 clearance

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

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