FDA device listing
DIO IDx
FDA device listing 1625037025 · DIO Corporation
Key facts
| Proprietary names | DIO IDx |
|---|---|
| Owner/operator | DIO Corporation |
| Owner/operator number | 9089142 |
| Premarket submissions | K142358 |
| Product codes | EKX |
| Device names | EKX - Handpiece, Direct Drive, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | DIO Corporation |
| Establishment registrations | 3007126709 |
| FEI numbers | 3007126709 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database