ORAL SAFE
Device Facts
| Record ID | K832359 |
|---|---|
| Device Name | ORAL SAFE |
| Applicant | Great Lakes Orthodontics, Ltd. |
| Product Code | JER · Dental |
| Decision Date | Sep 26, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3530 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.
