← Product Code [EHB](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB) · K903012

# AUDIOPRAT ENDOSCOPE (K903012)

_S.C.D.P.I. of Florida, Inc. · EHB · Oct 9, 1990 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K903012

## Device Facts

- **Applicant:** S.C.D.P.I. of Florida, Inc.
- **Product Code:** [EHB](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB.md)
- **Decision Date:** Oct 9, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1840
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K903012](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K903012)

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