FDA device listing
Aroma Fine,Aroma Fine Plus,GC Pas/Cion
FDA device listing 1781956869 · GC America Inc.
Key facts
| Proprietary names | Aroma Fine,Aroma Fine Plus,GC Pas/Cion |
|---|---|
| Owner/operator | GC America Inc. |
| Owner/operator number | 8030268 |
| Premarket submissions | K994077 |
| Product codes | ELW |
| Device names | ELW - Material, Impression |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3660 |
| Review panels | Dental |
| Registered establishments | GC AMERICA INC., GC CORP., GC CORPORATION-FUJI OYAMA FACTORY |
| Establishment registrations | 1410097, 9612300, 3002807050 |
| FEI numbers | 1410097, 3002807050, 3002808289 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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