Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013528406

FEI Number

3013528406

Entity Name

ZHEJIANG HEADWAY MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

No. 1859, Wenju Street, Fuchun Street, Fuyang District, Hangzhou City Zhejiang 311400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Headway Medical Equipment Co., Ltd. (Owner Number: 10053457)

Owner / Operator Contact Address

No. 1859, Wenju Street, Fuchun Street, Fuyang District, Hangzhou City, CN-ZJ 311400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthodontic Buccal Tubes Orthodontic Archwires Orthodontic Elastomeric Auxiliaries Orthodontic Bands Orthodontic Lingual Sheaths Orthodontic Power Hooks Orthodontic Crimpable Hooks Orthodontic Metal Brackets Orthodontic Lingual Buttons micro screw driver handles orthodontic tools self ligating tools Disposable Anti-particle Mask HW-001 HW-002 KN95

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2016-12-07
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2016-12-07
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2016-12-07
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2016-12-07
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-12-07
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-06-22
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-22

Official Correspondent

Guihua Zhan

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Zhejiang Headway 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
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
3006707038	MYOFUNCTIONAL RESEARCH CORP. PTY. LTD.	HELENSVALE Queensland, AU
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
1526352	SUMMIT ORTHODONTIC SERVICES, INC.	Schaumburg, IL, US
3014425175	Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, MX
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013528406. Last updated year: 2026. Please use registration number 3013528406 when referencing this establishment in official correspondence.