EKY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Handpiece, Water-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4200
- Medical specialty
- Dental
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 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 |
|---|---|---|
| TRAUS SIP10 (K123695) | Saeshin Precision Co., Ltd. | 2012-12-18 |
| DECIDENT (K896364) | Nevin Laboratories, Inc. | 1990-07-19 |
Track EKY automatically
Every clearance here is in the API, with alerts when new ones post.