TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
Device Facts
| Record ID | K000996 |
|---|---|
| Device Name | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND |
| Applicant | Dentsply Intl. |
| Product Code | EFT · Dental |
| Decision Date | Jun 16, 2000 |
| 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.
