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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2008-01-31 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-01-14 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-07-13 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2012-11-28 |
| Saliva, Artificial | LFD | Class U | Unknown | No | 2011-01-31 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-03-28 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2009-09-16 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2014-06-03 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2024-01-29 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2005-04-28 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2008-01-14 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2015-04-22 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2013-12-17 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2016-06-01 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2012-09-05 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2004-01-16 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-12-13 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2010-12-13 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2015-06-19 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2024-04-18 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2008-01-31 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2011-10-10 |
| Material, Impression | ELW | Class 2 | Dental | No | 2010-02-25 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2003-05-13 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2010-06-03 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | Class 1 | Dental | No | 2019-08-27 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2008-01-31 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2015-09-15 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2020-07-02 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2008-01-31 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2012-12-05 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2006-03-20 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2014-08-06 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2012-12-03 |
| Protector, Silicate | EFX | Class 1 | Dental | No | 2013-12-17 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2015-06-23 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2008-01-31 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2009-09-28 |
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