Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013519244

FEI Number

3013519244

Entity Name

HANGZHOU PENGWU MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

2nd Floor, Unit 18, No.619 Wangmei Road, Linping Street, Linping District, Hangzhou, China, Hangzhou Zhejiang 311100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANGZHOU PENGWU MEDICAL EQUIPMENT CO.,LTD (Owner Number: 10058484)

Owner / Operator Contact Address

2nd Floor, Unit 18, No.619 Wangmei Road, Linping Street, Linping District Hangzhou, China, Hangzhou, CN-ZJ 311100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SmileStreamSolutions / PW Ortho SmileStreamSolutions / PW Ortho SmileStreamSolutions / PW Ortho SmileStreamSolutions / PW Ortho SmileStreamSolutions / PW Ortho SmileStreamSolutions / PW Ortho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2018-10-04
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2018-10-04
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2019-12-09
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2018-10-04
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2018-10-04
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2018-10-04

Official Correspondent

Yue Wu

US Agent Details

Steven Liu Business: StevenLiu Email: steven960401@gmail.com Phone: (626) 8980360

Related Public Records

Same Entity

HANGZHOU PENGWU 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

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
3017092365	APNOMED, INC.	Bellevue, WA, US
1000385618	LEWA-DENTAL GMBH & CO. KG	REMCHINGEN Baden-Wurttemberg, DE
3009687180	KTJ DENTAL LAB COMPANY LIMITED	KL, HK
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN
3024749697	SPRINTRAY INC.	Huntington Beach, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013519244. Last updated year: 2026. Please use registration number 3013519244 when referencing this establishment in official correspondence.