Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003941201

FEI Number

3003941201

Entity Name

NIMI CHEMICAL INDUSTRIAL CO., LTD.

City/State/Country

Kiryu Gunma, JP

Establishment Address

4-13 Yokoyama-cho, Kiryu Gunma 376-0055, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

GC Tri Plaque ID Gel GC BITE COMPOUND SALIVA CHECK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2008-06-19
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2004-01-16

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003941201. Last updated year: 2026. Please use registration number 3003941201 when referencing this establishment in official correspondence.