FDA Registration Active 🇺🇸 United States

GC AMERICA INC.

Reg #: 1410097 · FEI: 1410097 · Expires 2026
Products
38
Proprietary Names
299
Establishment Types
5
Classifications
38

Registration Details

Registration Name
GC AMERICA INC.
Registration Number
1410097
FEI Number
1410097
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
3737 W 127th St
City
ALSIP
State
IL
ZIP
60803
Country
US

Regulatory Submissions

510(k) Number
K051358

Owner / Operator

Firm Name
GC America Inc.
Operator Number
8030268
Address
3737 W. 127th Street
City
Alsip
State
IL
Postal Code
60803
Country
US
Correspondent
Futoshi Fusejima

Products

Device Name Product Code
Resin, Denture, Relining, Repairing, Rebasing EBI
Crown And Bridge, Temporary, Resin EBG
Material, Tooth Shade, Resin EBF
Sealant, Pit And Fissure, And Conditioner EBC
Saliva, Artificial LFD
Powder, Porcelain EIH
Amalgamator, Dental, Ac-Powered EFD
Cement, Dental EMA
Bone Grafting Material, Synthetic LYC
Strip, Polishing Agent EHM
Sterilant, Medical Devices MED
Agent, Tooth Bonding, Resin KLE
Maintainer, Space Preformed, Orthodontic DYT
Wheel, Polishing Agent EJQ
Material, Impression Tray, Resin EBH
Wax, Dental, Intraoral EGD
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Tray, Impression, Preformed EHY
Aligner, Sequential NXC
Agent, Polishing, Abrasive, Oral Cavity EJR
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
Material, Impression ELW
Handle, Instrument, Dental EJB
Instruments, Dental Hand DZN
Device, Jaw Tracking, For Monitoring Jaw Positions NFS
Adhesive, Bracket And Tooth Conditioner, Resin DYH
Resin, Root Canal Filling KIF
Varnish, Cavity LBH
Dam, Rubber EIE
Alloy, Metal, Base EJH
Coating, Filling Material, Resin EBD
Activator, Ultraviolet, For Polymerization EBZ
Disinfectant, Medical Devices LRJ
Protector, Silicate EFX
Cleaner, Ultrasonic, Medical Instrument FLG
Syringe, Restorative And Impression Material EID
Post, Root Canal ELR

Proprietary Names

Nature-Cryl Super HI Impact Nature Cryl HI Plus Unifast LC Gradia Plus Diapolisher Paste Gradia Diapolisher Paste GC Gradia Diamond Polisher Revotek LC GC Dry Mouth Gel GC Oral Moisturizing Gel MSCB-001 Gradia Direct Flo Capsule Mixer CM-II Sympress 120 Ceramic Primer II Ceramic Primer Ceramic Primer II Unit Dose Fuji Filling LC Fuji Filling LC Self Conditioner GC Fuji Filling LC GC Fuji Filling LC Self Conditioner Foundation everX Flow POLISHING STRIPS Ultimate Finishing & Polishing Kit GC Metal Strips EPITEX EPITEX FINISHING HTFX-222 G-aenial Flo X Coe Cide XL G-Premio Bond everStickORTHO Ultimate F&P Kit Initial LiSi Block Coe Tray Plastic GC BITE COMPOUND SALIVA CHECK G-Fix GC Ortho Connect Flow Fuji Lining LC Paste Pak GC Fuji Lining LC Paste Pak GC Aadva Implant System Gradia Direct SOLARE SOLARE P Essentia Universal SOLARE BULK Coe Sideless Impression Tray Regular and Partial Tray Sto-K Tray Spacer Tray Perforated Tray Check Bite Tray McGowan -Winkler Impression Tray Stainless Steel Tray Depressed Anterior Tray Eon Aligner MI Paste Plus GC Tooth Mousse Plus MI Prophy Polish everX Posterior G-aenial Bond Unit Dose G-Bond Plus Solare Universal Bond G-aenial Bond Coe-Rect Kooliner Coe Cal FujiRock GC Aadva Scanner GC Aadva IOS LD-1 Milling Machiine GC Aadva IOS 200 GC Aadva IOS 100P Aadva Lab Scanner 3 Aadva Lab Scanner 2 Exa'Lence Putty Fusion Putty EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid APPLIER III Unitip Applier II Applier IV Paste Pak Dispenser Paste Pak Dispenser II GC Fuji Capsule Applier GC Capsule Applier V GC Initial Brush Optiglaze Tips Applicator Holder Microtip Applicator Gradia Brush Tips Gradia Gradia Composite Resin COE-PAK AUTOMIX NDS Coe-Pak Hard & Fast Set Standard Pak Coe-Pak Standard Pkg GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite StickSTEPPER StickCARRIER GC Occlusal Matrix Fuji Spatula Dental Prescale II MI PASTE MI Paste GC Tooth Mousse GC FujiCEM Evolve GC FujiCEM 2 (Improved) FIT CHECKER Coe Comfort G-CEM ONE ISO Functional Exajet GC Fuji ORTHO BAND PASTE PAK Nature-Cryl MC Alike Nogenol Root Canal Sealer GC Pas/Cion Aroma Fine Plus Aroma Fine Unifast III MI Flow Essentia G-aenial Flo GC Fuji Triage EP Coe Soft Coe Lubricant Coe Soft Print everStickPERIO GC TiON Gingival Protector G-Bond Exa'Lence Fast Fusion Fast GC Reline Powder, Liquid GC Reline MFP-051 G-aenial Sculpt G-aenial A-Chord JC-50 GC OPA-100 GC Gel Conditioner GC Fuji Ortho LC Paste Pak Automix ORTHO GEL CONDITIONER Initial Lustre Pastes NF Initial IQ Initial LiSi Initial PC Initial Initial TI Initial Spectrum Stains Initial Lustre Paste One Initial IQ SQIN Creation Creation CC Creation Magic Colour Creation ZI-CT, ZI-F Lisi PressVest Creation LS Initial One Initial Brush GC Fuji Direct GC Fuji Automix LC Fuji Duet Cytrans Granules FIT CHECKER II GC Reline II MSN-006 TEMPSMART Fuji Ortho LC ORTHO CONDITIONER GC Fuji ORTHO LC Aadva Ti Coloring Service Fixpeed Pattern Resin LS Nature Cryl HI-20ET Initial LiSi Press GC Lisi Press Vest Fujivest II GC FujiVest MI Varnish StickNET fibreNet G-Cem G-CEM CAPSULE GC Optiglaze G-Coat Plus G-COAT Unifast Trad G-aenial Injection Matrix Kit MI Fil G-aenial Universal Flo Fuji Varnish Fuji IX Fuji IX ART GC Gold Label 9 HS Post. Rest. Super-Soft Nature-Cryl Pour New Plastone AIM2 everStickC&B G-CEM Automix GC GAM-100 EXAFAST NDS EXAFAST PUTTY Universal VPS Adhesive EXAMIX NDS Intraoral Tips Universal/NDS GC Cartridge Dispenser GC Cartridge Dispenser II Plunger EXAFLEX IMPRESSION MATERIAL Dispensing Guns Plunger for Universal Dispenser Mixing Tips EXA Advanced Exa Advance GC Reline (Primer, Modifier, Bondin GC Reline Primer R GC Reline Primer M GC Reline Modifier GC Reline Bonding Agent GC Baseline The Light The Light 405 CoeFect Minute Wipes CoeFect Minute Spray StickREFIX ExaClear Exabite II NDS G-aenial Bulk Injectable G-aenial Universal Injectable NMF004A GC Fuji Ortho LC GC Initial ZR Disk HT GC Acrylic Primer Nanocoat Color Optiglaza Color Optiglaze GC Kalore GDLS-200 Silverlight fibreStick Stick Temp Advantage Nogenol Temporary Cement GC TEMP ADVANTAGE COE TEMP ADVANTAGE Cerasmart Cerasmart Universal Cerasmart 270 GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE everStickNET G2-Bond Universal BZF-29 G-2 Bond Universal Kit Coezyme Coe Ortho Alginate Impreceed Coe Alginate Coe Tray Adhesive Coe-Flex Omniflex G-Cera Orbit LC G-Cera Orbit Color Coe Hydrophilic Gel (GHG) Coe Cide IX Plus GC Temp PRINT GC Fuji Ortho Band LC Automix GC OPB-100 GC Mixing Tips for Ortho GC Fuji ORTHO BAND LC PASTE PAK EXA'Lence Exalence 370 Fuji Triage GC Fuji Triage Impression Syringes Coe Syringe G-Cem LinkForce Try-In Paste Multi Primer GC Dual Cure Activator G-Premio Bond DCA G-Multi Primer G-Cem LinkForce G-CEM Try-in Paste G-CEM Veneer Exaflex GC Fiber Post GC Pattern Resin

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Remanufacture Medical Device