KOT · Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Dental · 21 CFR 872.3490 · Class 1
Overview
| Product Code | KOT |
|---|---|
| Device Name | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium |
| Regulation | 21 CFR 872.3490 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
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.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | Dec 20, 1994 | SESE |
| K941365 | MPI DENTURE ADHESIVE FILM SEALS | Medical Polymers, Inc. | Apr 22, 1994 | SESE |
| K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | Oct 24, 1990 | SESE |
| K895818 | STEADFAST DENTURE ADHESIVE CREAM | Stiefel Research Institute, Inc. | Apr 3, 1990 | SESE |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. | Nov 1, 1988 | SESE |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Block Drug Company, Inc. | Jun 30, 1987 | SESE |
| K854430 | RIGIDENT CREAM | Armkel, LLC | Mar 4, 1986 | SESE |
| K831493 | DENTURE ADHESIVE SEALS | Johnson & Johnson Professionals, Inc. | Jun 30, 1983 | SESE |
Top Applicants
- Block Drug Company, Inc. — 2 clearances
- Teledyne Getz — 1 clearance
- Stiefel Research Institute, Inc. — 1 clearance
- Precision Dynamics Corp. — 1 clearance
- Medical Polymers, Inc. — 1 clearance
