GC America Inc.
Alsip, IL, US
GC AMERICA INC. appears in FDA device records in Alsip, IL. FDA records list 128 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 128FDA records hold 128 510(k) clearances for GC America Inc. between 1993 and 2026. The busiest year on record is 2008, with 11. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 8 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 4 |
| 2002 | 6 |
| 2003 | 4 |
| 2004 | 6 |
| 2005 | 7 |
| 2006 | 1 |
| 2007 | 7 |
| 2008 | 11 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 7 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 5 |
| 2025 | 3 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253317 | Cytrans™ Elashield | LYC | Substantially Equivalent | |
| K261246 | SRGC-06 | EBF | Substantially Equivalent | |
| K254109 | G-CEM UNIVERSAL | EMA | Substantially Equivalent | |
| K251124 | G-Bond Universal | KLE | Substantially Equivalent | |
| K250953 | EQUIA LC ONE | EMA | Substantially Equivalent | |
| K251946 | G aenial Universal Injectable II | EBF | Substantially Equivalent | |
| K200798 | G-CEM ONE | EMA | Substantially Equivalent | |
| K200682 | BZF-29 | KLE | Substantially Equivalent | |
| K192597 | Cytrans Granules | LYC | Substantially Equivalent | |
| K193113 | GC Temp Print | EBG | Substantially Equivalent | |
| K193484 | GC Fuji Triage EP | EMA | Substantially Equivalent | |
| K192260 | everX Flow | EBF | Substantially Equivalent | |
| K182854 | GC FujiCEM 2 (Improved) | EMA | Substantially Equivalent | |
| K180917 | GC Acrylic Primer | KLE | Substantially Equivalent | |
| K181011 | AIM2 | ELW | Substantially Equivalent | |
| K172382 | GC Fuji Direct | EMA | Substantially Equivalent | |
| K173500 | NMF004A | EBF | Substantially Equivalent | |
| K153130 | Initial LiSi Block | EIH | Substantially Equivalent | |
| K153325 | Gradia Plus | EBF | Substantially Equivalent | |
| K153231 | G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer | EMA | Substantially Equivalent | |
| K153136 | Initial LiSi Press | EIH | Substantially Equivalent | |
| K153127 | everX Posterior | EBF | Substantially Equivalent | |
| K152274 | MSCB-001 | EIH | Substantially Equivalent | |
| K153253 | GC Reline II | EBI | Substantially Equivalent | |
| K151541 | G-Fix | EBF | Substantially Equivalent | |
| K143140 | G-Premio BOND | KLE | Substantially Equivalent | |
| K141562 | MSN-006 | EBG | Substantially Equivalent | |
| K133182 | HTFX-222 | EBF | Substantially Equivalent | |
| K133824 | CERASMART | EBF | Substantially Equivalent | |
| K133836 | OPTIGLAZE COLOR | EBD | Substantially Equivalent | |
| K123631 | MFP-051 | EBF | Substantially Equivalent | |
| K113816 | GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV | NHA | Substantially Equivalent | |
| K120243 | GAM-200 | EMA | Substantially Equivalent | |
| K120521 | GC BLUE SILICONE | ELW | Substantially Equivalent | |
| K103234 | GC AADVA BO AC ABUTMENTS | NHA | Substantially Equivalent | |
| K110871 | FIT CHECKER ADVANCED | ELW | Substantially Equivalent | |
| K101346 | GC ORAL MOISTURIZING GEL | LFD | Substantially Equivalent | |
| K102808 | MI VARNISH | LBH | Substantially Equivalent | |
| K093749 | GC AADVA IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K101420 | GC FUJI TEMP | EMA | Substantially Equivalent | |
| K092020 | AADVA ZR COLORING LIQUID | EIH | Substantially Equivalent | |
| K091388 | GCUC-505 | EBF | Substantially Equivalent | |
| K091106 | EQUIA | EMA | Substantially Equivalent | |
| K090747 | MI FLOW (GCUC-450) | EBF | Substantially Equivalent | |
| K082740 | GC AADVA ZR DISK | EIH | Substantially Equivalent | |
| K082434 | GDLS-200 | EBF | Substantially Equivalent | |
| K082171 | GRADIA CORE | EBF | Substantially Equivalent | |
| K082768 | G-BOND PLUS | KLE | Substantially Equivalent | |
| K080724 | GC OPB-100 | DYH | Substantially Equivalent | |
| K080478 | GRADIA FORTE | EBF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1410097 | 1410097 | GC AMERICA INC. | 3737 W 127th St, ALSIP, IL 60803 US | 2026 | and 28 more, listed in full below |
| 3045816931 | 3045816931 | GC America Inc. | Carretera Federal 45, Irapuato-Silao KM 144 + 300 Parque Industrial Hybrid Park,, Guanajuato Mexico 36293 MX | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- NXCAligner, Sequential
- EJHAlloy, Metal, Base
- EFDAmalgamator, Dental, Ac-Powered
- LYCBone Grafting Material, Synthetic
- EMACement, Dental
- FLGCleaner, Ultrasonic, Medical Instrument
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- EIEDam, Rubber
- NFSDevice, Jaw Tracking, For Monitoring Jaw Positions
- LRJDisinfectant, Medical Devices
- EJBHandle, Instrument, Dental
- DZEImplant, Endosseous, Root-Form
- DZNInstruments, Dental Hand
- DYTMaintainer, Space Preformed, Orthodontic
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EBFMaterial, Tooth Shade, Resin
- ELRPost, Root Canal
- EIHPowder, Porcelain
- EFXProtector, Silicate
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- LFDSaliva, Artificial
- EBCSealant, Pit And Fissure, And Conditioner
- MEDSterilant, Medical Devices
- EHMStrip, Polishing Agent
- EIDSyringe, Restorative And Impression Material
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- EHYTray, Impression, Preformed
- LBHVarnish, Cavity
- EGDWax, Dental, Intraoral
- EJQWheel, Polishing Agent
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain