FDA device listing
disposable glasses; mask with face shield; disposable face shield; Safety Glasses,Protective Light Hand Shield; Medical…
FDA device listing 1633408400 · HUANGHUA DK DENTAL CO., LTD
Key facts
| Proprietary names | disposable glasses; mask with face shield; disposable face shield; Safety Glasses,Protective Light Hand Shield; Medical Face Shield With Frame |
|---|---|
| Owner/operator | HUANGHUA DK DENTAL CO., LTD |
| Owner/operator number | 10054767 |
| Product codes | KPY |
| Device names | KPY - Shield, Protective, Personnel |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.6500 |
| Review panels | Radiology |
| Registered establishments | HUANGHUA DK DENTAL CO., LTD |
| Establishment registrations | 3013463240 |
| FEI numbers | 3013463240 |
| Establishment operations | 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