Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004146043

FEI Number

3004146043

Entity Name

GC ASAHI CORPORATION

City/State/Country

AICHI, JP

Establishment Address

1-3-3 KACHIGAWA-CHO, KASUGAI-SHI, AICHI --, JP

Establishment Type(s)

Manufacture 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

K951555

PMA Number

N/A

All Registered Proprietary Names

POLISHING STRIPS Ultimate Finishing & Polishing Kit GC Metal Strips EPITEX EPITEX FINISHING Fuji Varnish Fuji IX Fuji IX ART GC Gold Label 9 HS Post. Rest.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2005-04-28
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
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
3003941201	NIMI CHEMICAL INDUSTRIAL CO., LTD.	Kiryu Gunma, JP

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

Similar Registrations

Registration Number	Establishment Name	Location
3037591931	DOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD.	GUANGZHOU Guangdong, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3011191212	ESTHETIC ORTHODONTIC COMPANY OF AMERICA LLC	St Petersburg, FL, US
3043149181	HANGZHOU WISE MEDICAL DEVICE CO.,LTD	Hangzhou Zhejiang, CN
3002807315	SYNERGY HEALTH STERILISATION UK LTD	Daventry Northamptonshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004146043. Last updated year: 2026. Please use registration number 3004146043 when referencing this establishment in official correspondence.