SEA-BOND
Device Facts
| Record ID | K863375 |
|---|---|
| Device Name | SEA-BOND |
| Applicant | Combe, Inc. |
| Product Code | KXX · Dental |
| Decision Date | Sep 19, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3450 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya 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.