FDA device listing
G-aenial Injection Matrix Kit,G-aenial Universal Flo,MI Fil
FDA device listing 1870320511 · GC America Inc.
Key facts
| Proprietary names | G-aenial Injection Matrix Kit,G-aenial Universal Flo,MI Fil |
|---|---|
| Owner/operator | GC America Inc. |
| Owner/operator number | 8030268 |
| Premarket submissions | K091388 |
| Product codes | EBC, EBF, LBH |
| Device names | EBC - Sealant, Pit And Fissure, And Conditioner, EBF - Material, Tooth Shade, Resin, LBH - Varnish, Cavity |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3260, 872.3690, 872.3765 |
| Review panels | Dental |
| Registered establishments | GC AMERICA INC., GC CORP., GC DENTAL PRODUCTS CORP. |
| Establishment registrations | 1410097, 9612300, 9613953 |
| FEI numbers | 1410097, 3002807052, 3002808289 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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