Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004046512

FEI Number

3004046512

Entity Name

TSUEN LEE METALS & PLASTIC TOYS FACTORY

City/State/Country

SHEN ZHEN CITY Guangdong, CN

Establishment Address

TONG HOU ROAD, PING WU TOWN, LUNG KWONG, SHEN ZHEN CITY Guangdong --, CN

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

StickSTEPPER StickCARRIER GC Occlusal Matrix Fuji Spatula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2010-06-03

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
9710611	STICK TECH LTD.	TURKU Pirkanmaa, FI
3003941201	NIMI CHEMICAL INDUSTRIAL CO., LTD.	Kiryu Gunma, JP

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3015235469	KOEHRER MEDICAL ENGINEERING GMBH	Neuss North Rhine-Westphalia, DE
1815540	TP ORTHODONTICS, INC.	LA PORTE, IN, US
3003963832	PDT, INC.	MSLA, MT, US
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004046512. Last updated year: 2026. Please use registration number 3004046512 when referencing this establishment in official correspondence.