STEADFAST DENTURE ADHESIVE POWDER
Device Facts
| Record ID | K910216 |
|---|---|
| Device Name | STEADFAST DENTURE ADHESIVE POWDER |
| Applicant | Stiefel Research Institute, Inc. |
| Product Code | KOM · Dental |
| Decision Date | Mar 29, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3400 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or without acacia intended to be applied to the base of a denture before the denture is inserted into patient's mouth to improve denture retention and comfort.
