Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004580125

FEI Number

3004580125

Entity Name

TIANJIN GAPADENT CO., LTD.

City/State/Country

TIANJIN, CN

Establishment Address

NO.24 FENGZE ROAD, (ZHANGJIAWO INDUSTRIAL AREA) AUTOMOTIVE INDUSTRIAL AREA, XIQING DISTRICT, TIANJIN 300380, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TIANJIN GAPADENT CO., LTD. (Owner Number: 9063886)

Owner / Operator Contact Address

NO.24 FENGZE ROAD, (ZHANGJIAWO INDUSTRIAL AREA) AUTOMOTIVE INDUSTRIAL AREA, XIQING DISTRICT, TIANJIN, CN-NOTA 300380, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GAPA GAPA GAPA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2011-09-01
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2004-06-02
EKM	Gutta-Percha	Dental	Class 1	872.3850	2004-06-02

Official Correspondent

HO SANG AN

US Agent Details

Dennis Xu Xu Business: Performance International, Corp. Email: ybx99@yahoo.com Phone: (919) 8590478

Related Public Records

Same Entity

TIANJIN GAPADENT CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

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1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004580125. Last updated year: 2026. Please use registration number 3004580125 when referencing this establishment in official correspondence.