Data / Medical devices / Japan / GC Corporation-Fuji Oyama Factory
GC Corporation-Fuji Oyama Factory: FDA-registered device maker in SUNTO-GUN, Shizuoka-Ken, Japan, 47 510(k) clearances
GC Corporation-Fuji Oyama Factory is registered with the FDA (registration 3002807050) in SUNTO-GUN, Shizuoka-Ken, Japan. It lists 14 device types. The FDA files 47 510(k) clearances under its listings, the newest dated May 18, 2026. 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
- 3002807050
- Address
- 584-1 Nakahinata Oyama-Cho, SUNTO-GUN, Shizuoka-Ken, Japan, 410-1307
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- September 8, 2004
- Registered through
- 2026
- Brand names listed
- 76 ELW BITE CHECKER SILICONE, 76 EMA LINING CEMENT, AIM2, Aroma Fine, Aroma Fine Plus, BULK FujiCEM(AutoCompatible), Cavity Conditioner, EQUIA and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 18, 2026 | K254109 | G-CEM UNIVERSAL | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 19, 2025 | K250953 | EQUIA LC ONE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 12, 2018 | K181011 | AIM2 | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 2, 2018 | K172382 | GC Fuji Direct | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 13, 2016 | K153130 | Initial LiSi Block | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 30, 2016 | K153136 | Initial LiSi Press | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 3, 2016 | K153253 | GC Reline II | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102808 | MI VARNISH | LBH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 17, 2010 | K101420 | GC FUJI TEMP | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 17, 2009 | K091106 | EQUIA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 10, 2008 | K072425 | JNE IMPLANT SYSTEM | DZE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 20, 2008 | K073283 | GC GAM-100 | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 15, 2008 | K073588 | GC MODELS OPA-100 AND JC-50 | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 15, 2007 | K070840 | GVC-100 | 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 14, 2006 | K061535 | GC XLC-100 CAPSULE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 20, 2005 | K052462 | G-COAT | EBD | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 22, 2005 | K051427 | GC FUJI FIL LC | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 3, 2005 | K050059 | G-LIGHT | EBZ | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 18, 2004 | K042348 | GRADIA DIRECT LOFLO | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 29, 2004 | K041471 | G-BOND | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 26, 2002 | K020578 | GC FUJI ORTHO BAND PASTE PAK | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020342 | UNIFIL FLOW | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| February 28, 2002 | K020117 | GC FUJI LINING LC PASTE PAK | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 29, 2001 | K013198 | FUJI VII CAPSULE | 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 27, 2000 | K994077 | AROMA FINE (NORMAL AND FAST SET) | ELW | 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 |
| June 25, 1998 | K981461 | GC FUJI ORTHO LC | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 16, 1998 | K981514 | GC FUJI BOND LC | KLE | 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 |
| May 24, 1996 | K961584 | FUJI II LC (IMPROVED) | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 24, 1996 | K961417 | GC FUJI ORTHO | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 27, 1995 | K953166 | FUJI BOND LC | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 23, 1995 | K951555 | FUJI IX | 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 |
| March 10, 1994 | K935961 | GC FUJI COAT LC | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 30, 1991 | K913884 | FUJI II LC | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| July 31, 1990 | K901999 | FUJI LINING CEMENT LIGHT CURE | EJK | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| May 16, 1988 | K880848 | FUJI CAP II CAPSULE & APPLIER | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| May 1, 1985 | K851469 | 76 ELW BITE CHECKER SILICONE | ELW | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| May 1, 1985 | K851468 | 76 EMA LINING CEMENT | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| October 18, 1984 | K842994 | EMA FREEGENOL DENTAL CEMENT | EMA | Substantially Equivalent | Int'L Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Cement, Dental
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Coating, Filling Material, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated May 18, 2026. 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.