Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005663302

FEI Number

3005663302

Entity Name

SINO ORTHO LIMITED

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

W01 No.4 JINJIADU ROAD SOUTH YUHANG DISTRICT, HANGZHOU Zhejiang 310000, CN

Establishment Type(s)

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

Owner / Operator

SINO ORTHO LIMITED (Owner Number: 9085340)

Owner / Operator Contact Address

W01 No.4 Jinjiadu South Road, YUHANG DISTRICT, HANGZHOU, ZHEJIANG, CN-ZJ 311113, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PLIERS, DENTAL root canal lingual retainer, dental screw bracket case Molar band buccal tube, molar tube COIL SPRINGS, DENTAL photographic mirror Cheek Retractor, Lip Retractor, Lateral Retractor, double side retractors, Lip depressors diamod burs protaper file

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJY	Pliers, Operative	Dental	Class 1	872.4565	2008-09-17
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2006-11-17
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2006-04-04
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2006-04-04
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2006-04-04
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2006-04-04
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2008-09-17
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-01-14
EIG	Retractor, All Types	Dental	Class 1	872.4565	2017-03-20
EJL	Bur, Dental	Dental	Class 1	872.3240	2006-11-17
EMR	File, Periodontic	Dental	Class 1	872.4565	2006-11-17

Official Correspondent

Andy Zheng

US Agent Details

SINA WU Business: MANAGER Email: tcadental@hotmail.com Phone: (626) 2370071

Related Public Records

Same Entity

SINO ORTHO LIMITED

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005663302. Last updated year: 2026. Please use registration number 3005663302 when referencing this establishment in official correspondence.