Data / Medical devices / Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt (KOO): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt (product code KOO, Class 1, 21 CFR 872.3490). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 30, 1994, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KOO
- Device class
- 1
- Regulation
- 872.3490
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| India | 2 |
| Liechtenstein | 1 |
| Germany | 1 |
| Austria | 1 |
| Italy | 1 |
| Ireland | 1 |
Makers of Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| New World Imports, Inc. | Nashville, TN, United States | Specification developer | 1 | November 30, 1994 | 0 | 0 | 0 | api.fda.gov |
| Andersonbrecon Inc. | Rockford, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bonyf AG | Vaduz, Liechtenstein | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blossom Pharmaceuticals | Mapusa Goa, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dabur India Ltd | Silvassa Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Etol Gesundheitspflege-Und Pharmaprodukte GMBH | Oberkirch Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fittydent Intl. GMBH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pasini Laboratorio Chimico S.N.C. | Burago Di Molgora Lombardy, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procter & Gamble Co. | Brown Summit, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procter & Gamble Co., Regulatory Affairs | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheffield Pharmaceuticals LLC | New London, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stafford-Miller Limited | DUNGARVAN Waterford(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uspharma Ltd | Miami Lakes, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 30, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.