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) → OFX — General Purpose Dental Tray

# OFX · General Purpose Dental Tray

_Dental · 21 CFR 872.6640 · Class 1_

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

## Overview

- **Product Code:** OFX
- **Device Name:** General Purpose Dental Tray
- **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 (0 of 0)

_No cleared devices on record._

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

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