KOO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3490
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2012: 107 · 2013: 24 · 2014: 8 · 2015: 79 · 2016: 11 · 2024: 29
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES (K945200) | Procter & Gamble Co. | 1994-11-30 |
| ORAFIX SPECIAL DENTURE ADHESIVE (K943486) | Smithkline Beecham Corp. | 1994-11-03 |
| PROFAST - DENTURE ADHESIVE FOR LOWER JAWS (K930335) | Fittydent-Altwirth & Schmitt GmbH | 1994-02-01 |
| NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K862876) | Block Drug Company, Inc. | 1986-08-29 |
Track KOO automatically
Every clearance here is in the API, with alerts when new ones post.