Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027241817

FEI Number

3027241817

Entity Name

GC Dental Mexicana, S.A. de C.V.

City/State/Country

Monterrey Nuevo Leon, MX

Establishment Address

22a Avenida No. 233, Cumbres, Monterrey Nuevo Leon 64610, MX

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

K070319

PMA Number

N/A

All Registered Proprietary Names

EQUIA Forte EQUIA Forte Fil EQUIA Forte Coat EQUIA EQUIA Forte HT Fil EQUIA Coat EQUIA Fil GC Gold Label Hybrid FUJI II LC CAPSULE GC Fuji Direct GC Fuji Automix LC Fuji Duet GC Gold Label 1 Luting and Lining FUJI I GC Fuji IX GP FAST GC Fuji IX GP Capsule FUJI IX GP GC FUJICEM BULK FujiCEM(AutoCompatible) GC Fuji Ortho LC GC FUJI IX GP EXTRA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-06-22
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-02-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-04-06
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-31
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-01-14
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2015-04-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2010-02-25

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-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027241817. Last updated year: 2026. Please use registration number 3027241817 when referencing this establishment in official correspondence.