Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003775534

FEI Number

3003775534

Entity Name

GC EUROPE N.V.

City/State/Country

LEUVEN Vlaams Brabant, BE

Establishment Address

Researchpark Haasrode - Leuven 1240, Interleuvenlaan 33, LEUVEN Vlaams Brabant 3001, BE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GC America Inc. (Owner Number: 8030268)

Owner / Operator Contact Address

3737 W. 127th Street, Alsip, IL 60803, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K980695

PMA Number

N/A

All Registered Proprietary Names

GC Fujii Plus No Etch Fuji Plus GC Fuji PLUS GC Fuji PLUS CONDITIONER GC Fuji PLUS CAPSULE GC FujiCEM Evolve GC FujiCEM 2 (Improved) Exajet 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 Temp PRINT GC Initial Zirconia Disk ST GC Initial Zirconia Disk HT GC Aadva Zr Disk GC Initial ZR Disk ML Elite GC Gold Label 1 Luting and Lining FUJI I

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-07-12
ELW	Material, Impression	Dental	Class 2	872.3660	2007-11-30
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2007-11-30
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-07-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2009-01-12
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31

Official Correspondent

Futoshi Fusejima

US Agent Details

Futoshi Fusejima Business: GC America Inc. Email: futoshi.fusejima@gc.dental Phone: (708) 9263050

Related Public Records

Same Entity

GC America Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027555943	GC Corporation Mishima Factory	Sunto-Gun Shizuoka, JP
3004146043	GC ASAHI CORPORATION	AICHI, JP
3001949270	WINNING APPLIANCE MANUFACTORY LIMITED	CHAI WAN HONG KONG Xinjiang, CN
3004046512	TSUEN LEE METALS & PLASTIC TOYS FACTORY	SHEN ZHEN CITY Guangdong, CN
9710611	STICK TECH LTD.	TURKU Pirkanmaa, FI

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
2022039	SCIENTIFIC PHARMACEUTICALS, INC.	POMONA, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775534. Last updated year: 2026. Please use registration number 3003775534 when referencing this establishment in official correspondence.