Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015276158

FEI Number

3015276158

Entity Name

ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

Building 1, 926 Changhong East Street, Fuxi Road, Deqing District, Huzhou Zhejiang 313200, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhejiang Eksen Medical Technology Co., Ltd (Owner Number: 10059984)

Owner / Operator Contact Address

Building 1, 926 Changhong East Street, Fuxi Road, Deqing District, Huzhou, CN-ZJ 313200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Elastics Orthodontic Hooks Screw Expansion; Orthodontic Expansion Screws; Orthodontic Appliance Root Canal Files Orthodontic Wire Orthodontic Tube LeapBar Class III Malocclusion; Palatal Expander Orthodontic Bracket; Lingual Button; LeapBar Class II Appliance; LeapBar Class II Corrector; LeapBar Class II Malocclusion; Bite Corrector; LeapBar Class III Appliance; LeapBar Class III Corrector; Orthodontic Plier Orthodontic Band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2019-03-18
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2019-03-18
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-05-21
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2019-03-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2019-03-18
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2019-03-18
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2019-03-18
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2019-03-18
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2019-03-18

Official Correspondent

Charles Shen

US Agent Details

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

Related Public Records

Same Entity

Zhejiang Eksen 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3008005217	US ORTHODONTIC PRODUCTS	Norwalk, CA, US
3009491780	Phoenix Orthodontics Inc	Marietta, GA, US
1833132	G & H Wire Company	Franklin, IN, US
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015276158. Last updated year: 2026. Please use registration number 3015276158 when referencing this establishment in official correspondence.