QGO · Composite Resin Warmer
Dental · 21 CFR 872.6100 · Class 1
Overview
| Product Code | QGO |
|---|---|
| Device Name | Composite Resin Warmer |
| Regulation | 21 CFR 872.6100 |
| Device Class | Class 1 |
| Review Panel | Dental |
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 | Compex HD | Addent, Inc. | Apr 29, 2019 | SESE |
Top Applicants
- Addent, Inc. — 1 clearance
