Company · US
GC America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
129510(k) clearances (4 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EMA | Cement, Dental | 30 |
| EBF | Material, Tooth Shade, Resin | 24 |
| ELW | Material, Impression | 15 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 12 |
| KLE | Agent, Tooth Bonding, Resin | 11 |
| EIH | Powder, Porcelain | 8 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 6 |
| EBG | Crown And Bridge, Temporary, Resin | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 |
| DZE | Implant, Endosseous, Root-Form | 2 |
| EBD | Coating, Filling Material, Resin | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 |
| LYC | Bone Grafting Material, Synthetic | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EIE | Dam, Rubber | 1 |
| LBH | Varnish, Cavity | 1 |
| LFD | Saliva, Artificial | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 10, 2026 | K262202 | Cerasmart Forte GC America, Inc. | EBF |
| Jul 6, 2026 | K253317 | Cytrans Elashield GC America, Inc. | LYC |
| Jun 18, 2026 | K261246 | SRGC-06 GC America, Inc. | EBF |
| May 18, 2026 | K254109 | G-CEM UNIVERSAL GC America, Inc. | EMA |
| Oct 2, 2025 | K251124 | G-Bond Universal GC America, Inc. | KLE |
| Sep 19, 2025 | K250953 | EQUIA LC ONE GC America, Inc. | EMA |
| Aug 29, 2025 | K251946 | G aenial Universal Injectable II GC America, Inc. | EBF |
| Nov 24, 2020 | K200798 | G-CEM ONE GC America, Inc. | EMA |
| Oct 2, 2020 | K200682 | BZF-29 GC America, Inc. | KLE |
| Aug 17, 2020 | K192597 | Cytrans Granules GC America, Inc. | LYC |
| Jul 9, 2020 | K193113 | GC Temp Print GC America, Inc. | EBG |
| Jul 2, 2020 | K193484 | GC Fuji Triage EP GC America, Inc. | EMA |
| Nov 22, 2019 | K192260 | everX Flow GC America, Inc. | EBF |
| Jul 11, 2019 | K182854 | GC FujiCEM 2 (Improved) GC America, Inc. | EMA |
| Nov 20, 2018 | K180917 | GC Acrylic Primer GC America, Inc. | KLE |
| Jul 12, 2018 | K181011 | AIM2 GC America, Inc. | ELW |
| Apr 2, 2018 | K172382 | GC Fuji Direct GC America, Inc. | EMA |
| Mar 8, 2018 | K173500 | NMF004A GC America, Inc. | EBF |
| Sep 13, 2016 | K153130 | Initial LiSi Block GC America, Inc. | EIH |
| Jul 12, 2016 | K153325 | Gradia Plus GC America, Inc. | EBF |
| Jul 6, 2016 | K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer GC America, Inc. | EMA |
| Jun 30, 2016 | K153136 | Initial LiSi Press GC America, Inc. | EIH |
| May 20, 2016 | K153127 | everX Posterior GC America, Inc. | EBF |
| Mar 25, 2016 | K152274 | MSCB-001 GC America, Inc. | EIH |
| Mar 3, 2016 | K153253 | GC Reline II GC America, Inc. | EBI |
| Oct 9, 2015 | K151541 | G-Fix GC America, Inc. | EBF |
| Apr 20, 2015 | K143140 | G-Premio BOND GC America, Inc. | KLE |
| Sep 5, 2014 | K141562 | MSN-006 GC America, Inc. | EBG |
| Apr 9, 2014 | K133182 | HTFX-222 GC America, Inc. | EBF |
| Mar 14, 2014 | K133824 | CERASMART GC America, Inc. | EBF |
| Mar 6, 2014 | K133836 | OPTIGLAZE COLOR GC America, Inc. | EBD |
| Jul 23, 2013 | K123631 | MFP-051 GC America, Inc. | EBF |
| Jan 30, 2013 | K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC America, Inc. | NHA |
| Jun 27, 2012 | K120243 | GAM-200 GC America, Inc. | EMA |
| May 10, 2012 | K120521 | GC BLUE SILICONE GC America, Inc. | ELW |
| Jun 30, 2011 | K103234 | GC AADVA BO AC ABUTMENTS GC America, Inc. | NHA |
| Jun 17, 2011 | K110871 | FIT CHECKER ADVANCED GC America, Inc. | ELW |
| Jan 27, 2011 | K101346 | GC ORAL MOISTURIZING GEL GC America, Inc. | LFD |
| Dec 22, 2010 | K102808 | MI VARNISH GC America, Inc. | LBH |
| Dec 6, 2010 | K093749 | GC AADVA IMPLANT SYSTEM GC America, Inc. | DZE |
| Sep 17, 2010 | K101420 | GC FUJI TEMP GC America, Inc. | EMA |
| Sep 29, 2009 | K092020 | AADVA ZR COLORING LIQUID GC America, Inc. | EIH |
| Jul 22, 2009 | K091388 | GCUC-505 GC America, Inc. | EBF |
| Jun 17, 2009 | K091106 | EQUIA GC America, Inc. | EMA |
| Jun 10, 2009 | K090747 | MI FLOW (GCUC-450) GC America, Inc. | EBF |
| Nov 26, 2008 | K082740 | GC AADVA ZR DISK GC America, Inc. | EIH |
| Nov 14, 2008 | K082434 | GDLS-200 GC America, Inc. | EBF |
| Oct 30, 2008 | K082171 | GRADIA CORE GC America, Inc. | EBF |
| Oct 21, 2008 | K082768 | G-BOND PLUS GC America, Inc. | KLE |
| Jun 11, 2008 | K080724 | GC OPB-100 GC America, Inc. | DYH |
Newest 50 of 129.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||