FDA device listing
ADJUSTABLE IMPRESSION TRAY,Autoclavable IMPRESSION tray,Disposable IMPRESSION tray,general tray,IMPLANT TRAY,Impression…
FDA device listing 1184390359 · Huanghua Promisee Dental Co., Ltd
Key facts
| Proprietary names | ADJUSTABLE IMPRESSION TRAY,Autoclavable IMPRESSION tray,Disposable IMPRESSION tray,general tray,IMPLANT TRAY,Impression tray base,TEETH WHITEING TRAY,tray base |
|---|---|
| Owner/operator | Huanghua Promisee Dental Co., Ltd |
| Owner/operator number | 10038868 |
| Product codes | EHY |
| Device names | EHY - Tray, Impression, Preformed |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6880 |
| Review panels | Dental |
| Registered establishments | HUANGHUA PROMISEE DENTAL CO., LTD |
| Establishment registrations | 3009420946 |
| FEI numbers | 3009420946 |
| 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