KOL
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3410
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2010: 513 · 2011: 271 · 2012: 74 · 2013: 35 · 2014: 30 · 2015: 47
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 |
|---|---|---|
| HOLD-FAST DENTURE ADHESIVE (K884999) | Iodent, Co. | 1989-02-24 |
| FORGET - DENTURE BONDING LIQUID (K791576) | Norcliff Thayer, Inc. | 1979-10-26 |
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Every clearance here is in the API, with alerts when new ones post.