Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640) → EBR — Unit, Suction Operatory

# EBR · Unit, Suction Operatory

_Dental · 21 CFR 872.6640 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR

## Overview

- **Product Code:** EBR
- **Device Name:** Unit, Suction Operatory
- **Regulation:** [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

## Classification Rationale

Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K925367](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR/K925367.md) | A-DEC 7284 CUSPIDOR, CASCADE | A-Dec, Inc. | Apr 11, 1994 | SESE |
| [K860058](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR/K860058.md) | DENPAX | Nissho Iwai American Corp. | Mar 12, 1986 | SESE |
| [K770600](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR/K770600.md) | OROPHARYNGEAL SUCTION AIRWAY | W.H. Wall, D.D.S. | Apr 8, 1977 | SESE |

## Top Applicants

- A-Dec, Inc. — 1 clearance
- Nissho Iwai American Corp. — 1 clearance
- W.H. Wall, D.D.S. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EBR)

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