Data / Medical devices / Mexico / GC Dental Mexicana, S.A. de C.V.
GC Dental Mexicana, S.A. de C.V.: FDA-registered device maker in Monterrey Nuevo Leon, Mexico, 11 510(k) clearances
GC Dental Mexicana, S.A. de C.V. is registered with the FDA (registration 3027241817) in Monterrey Nuevo Leon, Mexico. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 2, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3027241817
- Address
- 22a Avenida No. 233 Cumbres, Monterrey Nuevo Leon, Mexico, 64610
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Repackager or relabeler
- First device listed
- January 14, 2008
- Registered through
- 2026
- Brand names listed
- BULK FujiCEM(AutoCompatible), EQUIA, EQUIA Coat, EQUIA Fil, EQUIA Forte, EQUIA Forte Coat, EQUIA Forte Fil, EQUIA Forte HT Fil and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | 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 |
|---|---|---|---|---|---|---|
| April 2, 2018 | K172382 | GC Fuji Direct | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 17, 2009 | K091106 | EQUIA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 26, 2007 | K070319 | GC FUJI IX GP EXTRA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 17, 2000 | K001730 | GC FUJICEM | 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 |
| June 1, 1998 | K981370 | MIRACLE MIX CAPSULE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 13, 1998 | K980695 | FUJI I | 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 |
| March 8, 1995 | K950556 | FUJI ORTHO LC | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 20, 1995 | K946100 | FUJI DUET | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 16, 1988 | K880848 | FUJI CAP II CAPSULE & APPLIER | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Dental
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Material, Tooth Shade, Resin
Updated April 2, 2018. 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.