EJW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clasp, Wire
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3285
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2006: 3
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 |
|---|---|---|
| WIRONTOM CLASP WIRE (K901257) | Ivoclar North America, Inc. | 1990-04-25 |
| ORTHODONTIC NITINOL SPRINGS (K881331) | Flexmedics | 1988-04-21 |
| VITALLIUM WIRE (K872746) | Austenal Dental, Inc. | 1987-07-21 |
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Every clearance here is in the API, with alerts when new ones post.