FDA device listing
Preparer, Root Canal Endodontic
FDA device listing 1371071969 · I-Dent Innovations for Dentistry SA
Key facts
| Owner/operator | I-Dent Innovations for Dentistry SA |
|---|---|
| Owner/operator number | 10053667 |
| Product codes | EKQ |
| Device names | EKQ - Preparer, Root Canal Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | I-DENT INNOVATIONS FOR DENTISTRY SA |
| Establishment registrations | 3007113232 |
| FEI numbers | 3007113232 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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