Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021284315

FEI Number

3021284315

Entity Name

DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 602, Building 2, No.19 Tianxin Binhe Street, Huangjiang Town,, Dongguan Guangdong 523763, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan Integrity Medical Instrument Co.,Ltd. (Owner Number: 10083415)

Owner / Operator Contact Address

Room 602, Building 2, No.19 Tianxin Binhe Street, Huangjiang Town,, Dongguan, CN-GD 523763, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Absorbent Paper Points, Model:Taper 04/06 with LengthMark, for Protaper with LengthMark Absorbent Paper Points, Model: Taper 02, Taper 04/0/06, for Protaper, Taper 02 with LengthMark Gutta Percha Point, Model: for Protaper with LengthMark Gutta Percha Point, Model: Taper02, 04/06, for Protaper,Taper 02 with LengthMark,Taper 04/0/06 with LengthMark Barbed Broach (Nerve Broach) Length: 21mm/25mm Model: 0#,1#, 2#, 3#, 4#, 5#, 6#, 0-6# Paste carriers Stainless steel dental root canal files(K-files, H-files, Reamers, Spreaders, Pluggers, C+ files, U-files) Endodontic Root Canal Files: NiTi dental root canal files (K-files, H-files, Reamers, Spreaders, Pluggers) Hand use files (PT-files hand use, PT-files blue hand use) Engine endodontic files(Retreatment files,PT-files,PT-files blue,PT-files gold,PT-next, Only one gold, V-silver, V-blue Endodontic instruments (Gate drills, Peeso reamers) Blue Diamond Bur; Carbide Bur; Stainless Bur

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2025-12-10
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-12-10
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2022-11-13
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-11-18
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-12-10

Official Correspondent

Jianguo Li

US Agent Details

Christine Wang Email: Christinewang614@gmail.com Phone: (918) 9988916

Related Public Records

Same Entity

Dongguan Integrity Medical Instrument 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

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3011554142	SHENZHEN DENCO MEDICAL CO., LTD.	Shenzhen Guangdong, CN
2086043	PAC-DENT INC.	Brea, CA, US
3012996495	VIARDEN LAB LLC	Mission, TX, US
2024312	Kerr Corporation	ORANGE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021284315. Last updated year: 2026. Please use registration number 3021284315 when referencing this establishment in official correspondence.