EHS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cushion, Denture, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3540
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2002: 1
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 |
|---|---|---|
| SMILE WITH CONFIDENCE (K971002) | Lloyd V. Ziemendorf | 1997-07-15 |
| SOFT PLATE CUSHION (K813190) | Leonard Russo Co. | 1982-02-05 |
| CUSHIONS, DENTURE ADHESIVE, ALL-DAY (K770413) | Combe, Inc. | 1977-06-24 |
Track EHS automatically
Every clearance here is in the API, with alerts when new ones post.