FDA device listing
Rotary files/Root canal files, Hand use files/Manual files, Sterile Endodontic Hand Instruments
FDA device listing 1647296431 · United Dental Changzhou
Key facts
| Proprietary names | Rotary files/Root canal files, Hand use files/Manual files, Sterile Endodontic Hand Instruments |
|---|---|
| Owner/operator | United Dental Changzhou |
| Owner/operator number | 10062136 |
| Product codes | EKS |
| Device names | EKS - File, Pulp Canal, Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | UNITED DENTAL CHANGZHOU |
| Establishment registrations | 3015526995 |
| FEI numbers | 3015526995 |
| Establishment operations | Foreign Exporter, 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