Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009541709

FEI Number

3009541709

Entity Name

Huaxian Yuwei Dental Materials Factory

City/State/Country

Anyang City Henan, CN

Establishment Address

No. 2 East Industrial South Road, Mengzhuang S213 Provincial Road, Shangguan Town, Huaxian, Anyang City Henan 455000, CN

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Sterilize Medical Device for Another Party (Contract Sterilizer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Huaxian Yuwei Dental Materials Factory (Owner Number: 10039901)

Owner / Operator Contact Address

No.2 East Industrial South Road, Mengzhuang S213 Provincial Road, Shangguan Town, Huaxian, Anyang City, CN-HA 455000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RESTORATION, RESIN Yuwei Brand Synthetic Polymer Teeth (Mercury, Venus, Mars, Jupiter, Saturn, Uranus, Neptune ) Yuwei Brand Synthetic Polymer Teeth (Ecostar,Suplar.Neputas,Physioca,Typlus)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSM	Restoration, Resin	Unknown	Class N	N/A	2012-02-20
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2015-03-04

Official Correspondent

Ms. Zhang He

US Agent Details

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

Related Public Records

Same Entity

Huaxian Yuwei Dental Materials Factory

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3038107386	J&D DENTAL LAB	Uijeongbu Gyeonggi, KR
3034881111	MASTER DENTAL STUDIO	Palm Harbor, FL, US
3009488697	ZH GRACEFUL DENTAL LAB CO., LTD.	Zhuhai Guangdong, CN
3044707963	DIAMOND DENTAL LAB - BRANCH DIAMOND DENTAL GROUP COMPANY LIMITED	Tan Son Hoa Ward, Ho Chi Minh, VN
3038290056	SKY HKMC INTERNATIONAL LIMITED	HONG KONG, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009541709. Last updated year: 2026. Please use registration number 3009541709 when referencing this establishment in official correspondence.