CFR MONOGRAPH
Device Facts
| Record ID | K925259 |
|---|---|
| Device Name | CFR MONOGRAPH |
| Applicant | Combe, Inc. |
| Product Code | EFT · Dental |
| Decision Date | Jan 11, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3520 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.
