FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
Device Facts
| Record ID | K945200 |
|---|---|
| Device Name | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES |
| Applicant | Procter & Gamble Co. |
| Product Code | KOO · Dental |
| Decision Date | Nov 30, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3490 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.
