Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043655586

FEI Number

3043655586

Entity Name

FOSHAN ORECK MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Foshan City Guangdong, CN

Establishment Address

Factory Building 1, No.68 Guihe Road Yaotou Village Lishui Town Nanhai District, Foshan City Guangdong 528241, CN

Establishment Type(s)

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

Owner / Operator

Foshan ORECK Medical Technology Co.,Ltd (Owner Number: 10095032)

Owner / Operator Contact Address

Factory Building 1, No.68 Guihe Road Yaotou Village Lishui Town Nanhai District, Foshan City, CN-GD 528241, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Root canal enlarger (Gates drills, Pesso reamers, Fiber post drills) Root canal file, Endodontic file

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2026-01-16
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2026-01-16

Official Correspondent

Michelle Peng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Foshan ORECK Medical Technology 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
3016447764	DSI DENTAL SOLUTIONS LTD	Ashdod Southern, IL
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3006113314	SPIDENT CO., LTD.	INCHEON Gyeonggi, KR
2436986	META DENTAL CORP.	Glendale, NY, US
8030962	Micro-Mega SA	BESANCON Doubs, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043655586. Last updated year: 2026. Please use registration number 3043655586 when referencing this establishment in official correspondence.