Prosthetic devices · 21 CFR 872 Subpart D
Carboxymethylcellulose Sodium or Polyvinyl Methylether Maleic Acid Calcium-Sodium
FDA device type “Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium”.
- Companies listing it
- 129 makers
- Brands and models
- 16
- 510(k) clearances
- 80 in five years
- FDA name
- Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
510(k) clearances per year, 1976–2026
Companies that list KOT
12 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Manufacturera Dental Continental | Mexico | Maker | Confident Denture Adhesive Cream · Confident Denture Adhesive Powder | 2 | 2001 |
| Bonyf AG | Liechtenstein | Maker | Denture Adhesive Cream superior (DENTTACH CLASSIC - DENTTACH FRESH) · OlivaFix Denture Adhesive Cream (DENTTACH GREEN - DENTTACH GREEN FRESH) | 1 | 2006 |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | denture adhesive powder | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | denture adhesive powder | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Denture Adhesive Cream; Denture Adhesive Powder | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | denture adhesive cream; denture adhesive powder | — | — |
| Anhui Greenland Biotech Co.,Ltd | China | Maker | Avistar · extra strong denture adhesive cream · minty Flavor denture adhesive cream · original Flavor denture adhesive cream | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Denture Adhesive Cream; Denture Adhesive Powder | — | — |
| Blossom Pharmaceuticals | India | Maker | Denture Adhesive | — | — |
| DSI Dental Solutions Ltd | Israel | Manufacturer | — | 2 | 2025 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| WestRock Converting, LLC | United States | Repacker / relabeler | Poligrip Partials; Super Polygrip Cream; Super Poligrip Cushion & Comfort; Super Poligrip Powder | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Dec 1994 | K945462 | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. |
| 22 Apr 1994 | K941365 | MPI DENTURE ADHESIVE FILM SEALS | Medical Polymers, Inc. |
| 24 Oct 1990 | K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz |
| 3 Apr 1990 | K895818 | STEADFAST DENTURE ADHESIVE CREAM | Stiefel Research Institute, Inc. |
| 1 Nov 1988 | K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. |
| 30 Jun 1987 | K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Block Drug Company, Inc. |
| 4 Mar 1986 | K854430 | RIGIDENT CREAM | Armkel, LLC |
| 30 Jun 1983 | K831493 | DENTURE ADHESIVE SEALS | Johnson & Johnson Professionals, Inc. |
Official records: FDA product classification for KOT · 21 CFR 872.3490.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026