FDA device listing
Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills)
FDA device listing 1862056430 · Foshan ORECK Medical Technology Co.,Ltd
Key facts
| Proprietary names | Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills) |
|---|---|
| Owner/operator | Foshan ORECK Medical Technology Co.,Ltd |
| Owner/operator number | 10095032 |
| 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 | FOSHAN ORECK MEDICAL TECHNOLOGY CO.,LTD |
| Establishment registrations | 3043655586 |
| FEI numbers | 3043655586 |
| 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