FDA device listing
Chewing Gum, Torque Wrench, Locator Core Tool
FDA device listing 1909237379 · Shandong Hengfeng Kerui Medical Equipment Co., Ltd
Key facts
| Proprietary names | Chewing Gum, Torque Wrench, Locator Core Tool |
|---|---|
| Owner/operator | Shandong Hengfeng Kerui Medical Equipment Co., Ltd |
| Owner/operator number | 10090457 |
| Product codes | DZN |
| Device names | DZN - Instruments, Dental Hand |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD |
| Establishment registrations | 3031191035 |
| FEI numbers | 3031191035 |
| Establishment operations | Contract Manufacturer, 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