Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017941947

FEI Number

3017941947

Entity Name

JINING ORODEKA MEDICAL EQUIPMENT CO.,LTD

City/State/Country

JiNing Shandong, CN

Establishment Address

West 15 floor,XinChengFaZhan East Building Beihu District, JiNing Shandong 272000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

JINING ORODEKA MEDICAL EQUIPMENT CO.,LTD (Owner Number: 10079261)

Owner / Operator Contact Address

West 15 floor,XinChengFaZhan East Building Beihu District, JiNing, CN-SD 272000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

paper point gutta percha points Dental root canal instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2025-07-29
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-07-08
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2020-11-25

Official Correspondent

Mr Tian

US Agent Details

chen jimmy Business: UGK-LVM UNITED INC Email: 1841621950@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

JINING ORODEKA MEDICAL EQUIPMENT 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 3017941947. Last updated year: 2026. Please use registration number 3017941947 when referencing this establishment in official correspondence.