Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6100](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6100) → QGO — Composite Resin Warmer

# QGO · Composite Resin Warmer

_Dental · 21 CFR 872.6100 · Class 1_

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

## Overview

- **Product Code:** QGO
- **Device Name:** Composite Resin Warmer
- **Regulation:** [21 CFR 872.6100](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6100)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K182017](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/QGO/K182017.md) | Compex HD | Addent, Inc. | Apr 29, 2019 | SESE |

## Top Applicants

- Addent, Inc. — 1 clearance

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

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