KOM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Adhesive, Denture, Acacia And Karaya With Sodium Borate
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3400
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2001: 2 · 2007: 2
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 |
|---|---|---|
| STEADFAST DENTURE ADHESIVE POWDER (K910216) | Stiefel Research Institute, Inc. | 1991-03-29 |
Track KOM automatically
Every clearance here is in the API, with alerts when new ones post.