Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010669020

FEI Number

3010669020

Entity Name

HANGZHOU WESTLAKE BIOMATERIAL CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Blg. 2, No. 1 Lingang Rd. Renhe Subdistrict , Yuhang District, YUHANG DISTRICT, Hangzhou Zhejiang 311107, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hangzhou Westlake Biomaterial Co., Ltd. (Owner Number: 10045941)

Owner / Operator Contact Address

Blg. 2, No. 1 Lingang Rd. Renhe Subdistrict, Yuhang District, Hangzhou, CN-ZJ 311107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

XIHUBIOM Retractor, Orthodontic Retractor, Orthodontic (All types of orthodontic Retractors) XIHUBIOM Band, Preformed, Orthodontic Band, Preformed, Orthodontic (All types of orthodontic Stainless Steel bands) Mirrors, Mouth, Orthodontic (All types of Orthodontic Mirror( Stainless and Glass)) Mirrors, Mouth, Orthodontic Mirror XIHUBIOM Instrument, Ligature Tucking, Orthodontic (All types of orthodontic Instruments) Instrument, Ligature Tucking, Orthodontic Maintainer, Space Preformed, Orthodontic Maintainer, Space Preformed, Orthodontic (All types of Maintainers) XIHUBIOM Retainer, Screw Expansion, Orthodontic (All types of Orthodontic Retainer and Expansion Screw) Retainer, Screw Expansion, Orthodontic ORTHODONTIC RETRACTION SCREWS Westlake Wire, Orthodontic Wire, Orthodontic (All type of NITI and Stainless Steel wire and Springs) XIHUBIOM Plier, Orthodontic Plier, Orthodontic (All types of orthodontic pliers) Accessories, Implant, Dental, Endosseous (All types of Orthodontic Accessories, Implants) Accessories, Implant, Dental, Endosseous

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2014-01-15
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2014-01-15
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2022-11-13
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2014-01-15
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2024-08-08
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2014-01-15
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2014-01-15
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2014-01-15
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-08-08

Official Correspondent

DONG RU

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Westlake Biomaterial 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-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3014647261	RETRACT EEZ, INC.	Largo, FL, US
3033892080	TALENT TECHNOLOGY MOULD CO., LIMITED	Shenzhen Guangdong, CN
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010669020. Last updated year: 2026. Please use registration number 3010669020 when referencing this establishment in official correspondence.