KOQ · Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Dental · 21 CFR 872.3410 · Class 1
Overview
| Product Code | KOQ |
|---|---|
| Device Name | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) |
| Regulation | 21 CFR 872.3410 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K901882 | URESIL ENDOSCOPIC LASER OVERTUBE | Uresil Corp. | Jul 27, 1990 | SESE |
| K900401 | NAS&P GRASPING FORCEPS & ASSOC. DEVICES | North American Sterilization & Packaging Co. | Feb 9, 1990 | SESE |
| K896821 | OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE | North American Sterilization & Packaging Co. | Feb 9, 1990 | SESE |
| K831265 | DENTOLOCK DENTURE ADHESIVE CREAM | Solar Dental Co., Inc. | May 9, 1983 | SESE |
Top Applicants
- North American Sterilization & Packaging Co. — 2 clearances
- Solar Dental Co., Inc. — 1 clearance
- Uresil Corp. — 1 clearance
