Data / Medical devices / Japan / GC Corp.
GC Corp.: FDA-registered device maker in ITABASHI-KU Tokyo, Japan, 76 510(k) clearances
GC Corp. is registered with the FDA (registration 9612300) in ITABASHI-KU Tokyo, Japan. It lists 23 device types. The FDA files 76 510(k) clearances under its listings, the newest dated July 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612300
- FEI number
- 3002808289
- Address
- 76-1 Hasunuma-Cho, ITABASHI-KU Tokyo, Japan, 174-8585
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 20, 1998
- Registered through
- 2026
- Brand names listed
- 76 EMA LINING CEMENT, AIM2, APPLIER III, Applicator Holder, Applier IV, Aroma Fine, Aroma Fine Plus, BULK FujiCEM(AutoCompatible) 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 |
|---|---|---|---|---|---|---|
| July 6, 2026 | K253317 | Cytrans Elashield | LYC | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| 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 |
| August 29, 2025 | K251946 | G aenial Universal Injectable II | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 24, 2020 | K200798 | G-CEM ONE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 17, 2020 | K192597 | Cytrans Granules | LYC | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 2, 2020 | K193484 | GC Fuji Triage EP | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 22, 2019 | K192260 | everX Flow | EBF | 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 |
| 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 |
| March 8, 2018 | K173500 | NMF004A | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 13, 2016 | K153130 | Initial LiSi Block | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 12, 2016 | K153325 | Gradia Plus | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 6, 2016 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | EMA | 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 |
| March 14, 2014 | K133824 | CERASMART | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 23, 2013 | K123631 | MFP-051 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 30, 2013 | K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV | NHA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 29, 2011 | K111087 | FOUNDATION | LYC | Substantially Equivalent | Olympus Terumo Biomaterials Corporation | accessdata.fda.gov |
| June 17, 2011 | K110871 | FIT CHECKER ADVANCED | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 27, 2011 | K101346 | GC ORAL MOISTURIZING GEL | LFD | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| December 22, 2010 | K102808 | MI VARNISH | LBH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| December 6, 2010 | K093749 | GC AADVA IMPLANT SYSTEM | DZE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 17, 2010 | K101420 | GC FUJI TEMP | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 22, 2009 | K091388 | GCUC-505 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 17, 2009 | K091106 | EQUIA | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 30, 2008 | K082171 | GRADIA CORE | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 11, 2008 | K080724 | GC OPB-100 | DYH | 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 14, 2008 | K072100 | GC AADVA ABUTMENT | NHA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 15, 2007 | K070840 | GVC-100 | 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 |
| June 29, 2004 | K041471 | G-BOND | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 20, 2003 | K032289 | FIT CHECKER II | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 30, 2003 | K023814 | GRADIA DIRECT | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 18, 2002 | K022430 | ISO FUNCTIONAL | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 3, 2002 | K021038 | GC ELITE CEMENT 100 | EMA | 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 |
| February 20, 2002 | K013997 | UNIFIL BOND | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 29, 2001 | K013198 | FUJI VII CAPSULE | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 16, 2001 | K003817 | PATTERN RESIN | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 17, 2000 | K001730 | GC FUJICEM | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 5, 2000 | K001518 | GRADIA | EBF | 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 25, 1999 | K984365 | GC UNIFAST TRAD | EBI | 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 |
| April 3, 1998 | K980682 | FUJI II | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 26, 1997 | K972594 | METALPRIMER II | KLE | 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 |
| October 18, 1994 | K942670 | GC PATTERN RESIN | EBG | 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 |
| September 29, 1993 | K933206 | EXA BITE REGISTRATION MATERIAL | ELW | 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 |
| December 22, 1989 | K894282 | FIRST IMPRESSION TM | ELW | Substantially Equivalent | Coe Laboratories, Inc. | accessdata.fda.gov |
| May 1, 1985 | K851468 | 76 EMA LINING CEMENT | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| October 6, 1981 | K812680 | G-C IMPRESSION SYRINGE | EID | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
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Updated July 6, 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.