KOT
8 FDA 510(k) clearances · Product code
51 daysmedian time to decision
186 days90th percentile
8clearances measured
FDA profile
- Official device name
- Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3490
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2018: 95 · 2019: 54 · 2020: 90 · 2021: 88 · 2022: 51 · 2023: 71
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 |
|---|---|---|
| SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K945462) | Block Drug Company, Inc. | 1994-12-20 |
| MPI DENTURE ADHESIVE FILM SEALS (K941365) | Medical Polymers, Inc. | 1994-04-22 |
| SUPER STRENGTH DENTURE ADHESIVE CREAM (K903568) | Teledyne Getz | 1990-10-24 |
| STEADFAST DENTURE ADHESIVE CREAM (K895818) | Stiefel Research Institute, Inc. | 1990-04-03 |
| PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (K884357) | Precision Dynamics Corp. | 1988-11-01 |
| SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (K872225) | Block Drug Company, Inc. | 1987-06-30 |
| RIGIDENT CREAM (K854430) | Armkel, LLC | 1986-03-04 |
| DENTURE ADHESIVE SEALS (K831493) | Johnson & Johnson Professionals, Inc. | 1983-06-30 |
Track KOT automatically
Every clearance here is in the API, with alerts when new ones post.