FDA device listing
Creation,Creation CC,Creation LS,Creation Magic Colour,Creation ZI-CT, ZI-F,Initial,Initial Brush,Initial IQ,Initial IQ…
FDA device listing 1489105514 · GC America Inc.
Key facts
| Proprietary names | Creation,Creation CC,Creation LS,Creation Magic Colour,Creation ZI-CT, ZI-F,Initial,Initial Brush,Initial IQ,Initial IQ SQIN,Initial LiSi,Initial Lustre Paste One,Initial Lustre Pastes NF,Initial One,Initial PC,Initial Spectrum Stains,Initial TI,Lisi PressVest |
|---|---|
| Owner/operator | GC America Inc. |
| Owner/operator number | 8030268 |
| Premarket submissions | K040567 |
| Product codes | EIH |
| Device names | EIH - Powder, Porcelain |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.6660 |
| Review panels | Dental |
| Registered establishments | GC AMERICA INC., GC DENTAL PRODUCTS CORP., GC EUROPE N.V., Klema Dentalprodukte GMBH |
| Establishment registrations | 1410097, 9613953, 3003775534, 3005974404 |
| FEI numbers | 1410097, 3002807052, 3003775534, 3005974404 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1,000+ 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