Data / Medical devices / Belgium / GC Europe N.V.
GC Europe N.V.: FDA-registered device maker in LEUVEN Vlaams Brabant, Belgium, 7 510(k) clearances
GC Europe N.V. is registered with the FDA (registration 3003775534) in LEUVEN Vlaams Brabant, Belgium. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 9, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003775534
- Address
- Researchpark Haasrode - Leuven 1240 Interleuvenlaan 33, LEUVEN Vlaams Brabant, Belgium, 3001
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 20, 1998
- Registered through
- 2026
- Brand names listed
- Aadva Lab Scanner 2, Aadva Lab Scanner 3, Articulating Paper, Coe Cal, Creation, Creation CC, Creation LS, Creation Magic Colour and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2020 | K193113 | GC Temp Print | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 11, 2019 | K182854 | GC FujiCEM 2 (Improved) | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 26, 2008 | K082740 | GC AADVA ZR DISK | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 22, 2004 | K040567 | GC INITIAL MC, AL AND LF | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 22, 2003 | K023751 | EXAJET | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 13, 1998 | K980695 | FUJI I | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 20, 1995 | K946100 | FUJI DUET | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Material, Impression
- All makers of Cement, Dental
- All makers of Powder, Porcelain
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Paper, Articulation
Updated July 9, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.