Prosthetic devices · 21 CFR 872 Subpart D
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture Adhesive
FDA device type “Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt”.
- Companies listing it
- 2114 makers
- Brands and models
- 31
- 510(k) clearances
- 40 in five years
- FDA name
- Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
510(k) clearances per year, 1976–2026
Companies that list KOO
21 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| Prestige Brands Holdings, Inc. | United States | Maker | Effergrip Denture Adhesive | 1 | 2013 |
| Bonyf AG | Liechtenstein | Maker | OlivaFix Gold Denture Adhesive Cream - DENTTACH Gold | 1 | 2006 |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Denture Adhesive | — | — |
| Haleon | United States | Maker | SUPER POLIGRIP FREE CREAM | — | — |
| Sheffield Pharmaceuticals LLC | United States | Maker | Combe Denture Adhesive Cream · Dawn Mist Denture Adhesive · Dr. Berland's Adhesadent Moisturizing Denture Adhesive · Dr. Sheffield Staydent Adhesive · +7 | — | — |
| Fittydent Int. GmbH | Austria | Maker | PROFAST ADHESIVE · Secure Denture Adhesive | — | — |
| Dabur India Limited | India | Maker | Dabur · Freshmint · IODENT · Personal Care | — | — |
| New World Imports, Inc. | United States | Maker | CareALL · Freshmint | — | — |
| Blossom Pharmaceuticals | India | Maker | Denture Adhesive | — | — |
| AndersonBrecon Inc. | United States | Maker | Fixodent | — | — |
| USpharma Ltd | United States | Maker | Cushion Grip | — | — |
| Etol Gesundheitspflege-und Pharmaprodukte GmbH | Germany | Maker | — | — | — |
| Pasini Laboratorio Chimico S.n.c. | Italy | Maker | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| Medline Industries, LP | United States | Contract sterilizer | SparkleFresh Denture Adhesive Cream | — | — |
| Dukal Corporation | United States | Specification developer | DawnMist Denture Adhesive | — | — |
| Summit Packaging Solutions LLC | United States | Repacker / relabeler | Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
| Advanced Concept Innovations LLC | United States | Repacker / relabeler | Fixodent | — | — |
| Honest Pharma LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 30 Nov 1994 | K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | Procter & Gamble |
| 3 Nov 1994 | K943486 | ORAFIX SPECIAL DENTURE ADHESIVE | Smithkline Beecham Corp. |
| 1 Feb 1994 | K930335 | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | Fittydent-Altwirth & Schmitt GmbH |
| 29 Aug 1986 | K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. |
Official records: FDA product classification for KOO · 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