Data / Medical devices / Japan / GC Dental Products Corp.
GC Dental Products Corp.: FDA-registered device maker in KASUGAI-SHI Aichi, Japan, 49 510(k) clearances
GC Dental Products Corp. is registered with the FDA (registration 9613953) in KASUGAI-SHI Aichi, Japan. It lists 15 device types. The FDA files 49 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613953
- FEI number
- 3002807052
- Address
- 2-285 Toriimatsu-Cho, KASUGAI-SHI Aichi, Japan, 486-0844
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 13, 2003
- Registered through
- 2026
- Brand names listed
- APPLIER III, Applicator Holder, Applier IV, BZF-29, Ceramic Primer, Ceramic Primer II, Ceramic Primer II Unit Dose, Cerasmart and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 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 |
|---|---|---|---|---|---|---|
| June 18, 2026 | K261246 | SRGC-06 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 2, 2025 | K251124 | G-Bond Universal | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 2, 2020 | K200682 | BZF-29 | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 22, 2019 | K192260 | everX Flow | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 20, 2018 | K180917 | GC Acrylic Primer | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 8, 2018 | K173500 | NMF004A | EBF | 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 |
| May 20, 2016 | K153127 | everX Posterior | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 9, 2015 | K151541 | G-Fix | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 16, 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | DYH | Substantially Equivalent | Gc Orthodontics America, Inc. | accessdata.fda.gov |
| May 7, 2015 | K143667 | GC KommonBase | DYH | Substantially Equivalent | Gc Orthodontics America, Inc. | accessdata.fda.gov |
| April 20, 2015 | K143140 | G-Premio BOND | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 5, 2014 | K141562 | MSN-006 | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 9, 2014 | K133182 | HTFX-222 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 14, 2014 | K133824 | CERASMART | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 6, 2014 | K133836 | OPTIGLAZE COLOR | EBD | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 23, 2013 | K123631 | MFP-051 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 10, 2012 | K120521 | GC BLUE SILICONE | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 30, 2011 | K103234 | GC AADVA BO AC ABUTMENTS | NHA | 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 |
| July 22, 2009 | K091388 | GCUC-505 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 10, 2009 | K090747 | MI FLOW (GCUC-450) | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| November 14, 2008 | K082434 | GDLS-200 | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 21, 2008 | K082768 | G-BOND PLUS | KLE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 5, 2008 | K080478 | GRADIA FORTE | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 11, 2008 | K073106 | UNIFAST III | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 9, 2007 | K071674 | GC-ZIRCONIA | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 12, 2007 | K070190 | GRADIA DIRECT X | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 4, 2005 | K043493 | FUSION PUTTY TYPE | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 27, 2005 | K043471 | FUSION FAST | ELW | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 25, 2005 | K043301 | GC TION GINGIVAL PROTECTOR | EIE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| June 25, 2004 | K041398 | GC FUSION | ELW | 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 |
| February 2, 2004 | K033808 | GRADIA GUM | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 30, 2003 | K023814 | GRADIA DIRECT | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 16, 2001 | K012542 | REVOTEK LC | EBC | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 16, 2001 | K003817 | PATTERN RESIN | EBG | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| August 16, 2000 | K001823 | LINKMAX | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 5, 2000 | K001518 | GRADIA | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| July 9, 1999 | K991774 | ACRON MC MODIFICATION | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 28, 1999 | K990736 | GC RELINE SOFT/EXTRA SOFT | EBI | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| October 19, 1998 | K982695 | GC RELINE | EBI | 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, 1993 | K932039 | G-CERA ORBIT COLOUR COMMUNICATION SET | EIH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| April 17, 1989 | K890829 | UNIFAST LC | EBG | 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 |
| October 6, 1981 | K812679 | G-C FIT-CHECKER IMPRESSION MATERIAL | ELW | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
| October 6, 1981 | K812406 | EXAFLEX IMPRESSION MATERIAL | ELW | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Tooth Shade, Resin
- All makers of Material, Impression
- All makers of Handle, Instrument, Dental
- All makers of Agent, Tooth Bonding, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Powder, Porcelain
Updated June 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.