OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
Device Facts
| Record ID | K896821 |
|---|---|
| Device Name | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE |
| Applicant | North American Sterilization & Packaging Co. |
| Product Code | KOQ · Dental |
| Decision Date | Feb 9, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3410 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing ethylene oxide homopolymer and/or carboxymethylcellulose sodium 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.