Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009646973

FEI Number

3009646973

Entity Name

HANGZHOU XINGCHEN 3B DENTAL INSTRUMENT & MATERIALS CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.619, Guoting Street, Chunjiang subdistrict, Fuyang District, Hangzhou Zhejiang 311421, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd (Owner Number: 10040829)

Owner / Operator Contact Address

No 619 Guoting Street, Chunjiang Subdistrict, Fuyang district, Hangzhou, CN-ZJ 311421, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

hangzhou 3B hangzhou 3B Hangzhou Xingchen 3B Dental Instrument & Material Co., Ltd. Hangzhou 3B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2012-05-23
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2012-05-23
EJY	Pliers, Operative	Dental	Class 1	872.4565	2015-04-28
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2012-05-23

Official Correspondent

Qijun Ni

US Agent Details

Rose Hou Business: ORJ Email: roseh@fortuneworldwide.com Phone: (214) 7242092

Related Public Records

Same Entity

Hangzhou Xingchen 3B Dental Instrument & Materials 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009646973. Last updated year: 2026. Please use registration number 3009646973 when referencing this establishment in official correspondence.