Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003850991

FEI Number

3003850991

Entity Name

Zhejiang Shinye Medical Technology Corp.,Ltd

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

No.1032 Tongyi Road, GONGSHU DISTRICT, HANGZHOU Zhejiang 310015, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Shinye Medical Technology Corp.,Ltd (Owner Number: 9053329)

Owner / Operator Contact Address

1032 Tongyi Road, Gongshu District, Hangzhou, CN-ZJ 310015, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BRACKET TUBE SPRING BAND WIRE CLAMP SCREW EXPANSION RETAINER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2002-10-11
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2002-10-11
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2002-10-11
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2002-10-11
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2002-10-11
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2002-10-11
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2002-10-11

Official Correspondent

Alice ShinYe

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

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

Similar Registrations

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3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003850991. Last updated year: 2026. Please use registration number 3003850991 when referencing this establishment in official correspondence.