Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5820](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5820) → BRW — Protector, Dental

# BRW · Protector, Dental

_Anesthesiology · 21 CFR 868.5820 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW

## Overview

- **Product Code:** BRW
- **Device Name:** Protector, Dental
- **Regulation:** [21 CFR 868.5820](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5820)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A dental protector is a device intended to protect a patient's teeth during manipulative procedures within a patient's oral cavity.

## 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 § 868.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945727](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW/K945727.md) | CATCO NEONATAL PALATE GUARD | Catco Medical, Inc. | Dec 7, 1994 | SESE |
| [K935713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW/K935713.md) | WILEY/ESPOSITO DENTAL GUARD | Fvtnks | Jan 5, 1994 | SESE |
| [K851640](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW/K851640.md) | TIP TOLEDO INCISOR PROTECTOR | Edward O. Goodwich | Sep 18, 1985 | SESE |

## Top Applicants

- Catco Medical, Inc. — 1 clearance
- Edward O. Goodwich — 1 clearance
- Fvtnks — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BRW)

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