Data / Medical devices / Mexico / GC America Inc.
GC America Inc.: FDA-registered device maker in Guanajuato Mexico, Mexico, 7 510(k) clearances
GC America Inc. is registered with the FDA (registration 3045816931) in Guanajuato Mexico, Mexico. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045816931
- Address
- Carretera Federal 45, Irapuato-Silao KM 144 + 300 Parque Industrial Hybrid Park, Int 26, 27, 33 Ejido de Vallejos, Guanajuato Mexico, Mexico, 36293
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- January 31, 2008
- Registered through
- 2026
- Brand names listed
- EQUIA, EQUIA Coat, EQUIA Fil, EQUIA Forte, EQUIA Forte Coat, EQUIA Forte Fil, EQUIA Forte HT Fil, FUJI II LC CAPSULE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Exporter to the US, Repackager or relabeler | 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 2, 2020 | K193484 | GC Fuji Triage EP | EMA | 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 |
| December 22, 2010 | K102808 | MI VARNISH | LBH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 17, 2009 | K091106 | EQUIA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 11, 2000 | K993973 | FUJI II LC CAPSULE | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 4, 1999 | K984505 | MIRACLE MIX POWDER/LIQUID | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 8, 1996 | K961448 | FUJI IX GP | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 2, 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.