Hangzhou Westlake Biomaterial Co., Ltd.

Registered establishment in Hangzhou, Zhejiang, China. 13 device types.

Registry build 21.09.26

Hangzhou Westlake Biomaterial Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mirror, Mouth, Tube, Orthodontic and 11 other device types. Its earliest product listing with the FDA dates from 2014.

Registration

FDA registration record for Hangzhou Westlake Biomaterial Co., Ltd.
Registered name HANGZHOU WESTLAKE BIOMATERIAL CO., LTD.
Status Registered
Registration expires 2026
Registration number 3010669020
FEI number 3010669020
Establishment type Contract manufacturer, Manufacturer, Exporter

Location

Address of Hangzhou Westlake Biomaterial Co., Ltd.
City Hangzhou
Province Zhejiang
Address Blg. 2, No. 1 Lingang Rd. Renhe Subdistrict , Yuhang District
Postal code 311107
Country China

What It Makes

Device types Hangzhou Westlake Biomaterial Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Implant, Dental, Endosseous Class 1 Accessories, Implant, Dental, Endosseous, Accessories, Implant, Dental, Endosseous (All types of Orthodontic Accessories, Implants) 2024 70
Band, Elastic, Orthodontic Class 1 Orthodontic Elastics, Band, Elastic, Orthodontic (All types of orthodontic Elastic Bands, Power Chain, Sleeve, Thread, Seperator), Band, Elastic, Orthodontic 2020 36
Band, Preformed, Orthodontic Class 1 Xihubiom, Band, Preformed, Orthodontic (All types of orthodontic Stainless Steel bands), Band, Preformed, Orthodontic 2014 27
Bracket, Metal, Orthodontic Class 1 Xihubiom, Orthodontic Bracket, Metal Brackets, Orthodontic Brackets, Ceramic Brackets, Sapphire Brackets and 2 more 2014 52
Clamp, Wire, Orthodontic Class 1 Archwire Stop, Lingual button, Orthodontic Lingual Button, Clamp, Wire, Orthodontic, Leapbar, Face Masks and 3 more 2022 27
Instrument, Ligature Tucking, Orthodontic Class 1 Xihubiom, Instrument, Ligature Tucking, Orthodontic, Instrument, Ligature Tucking, Orthodontic (All types of orthodontic Instruments) 2014 10
Maintainer, Space Preformed, Orthodontic Class 1 Maintainer, Space Preformed, Orthodontic, Maintainer, Space Preformed, Orthodontic (All types of Maintainers) 2024 18
Mirror, Mouth Class 1 Mirrors, Mouth, Orthodontic (All types of Orthodontic Mirror( Stainless and Glass)), Mirrors, Mouth, Orthodontic, Mirror 2022 94
Plier, Orthodontic Class 1 Xihubiom, Plier, Orthodontic, Plier, Orthodontic (All types of orthodontic pliers) 2014 28
Retainer, Screw Expansion, Orthodontic Class 1 Xihubiom, Retainer, Screw Expansion, Orthodontic, Retainer, Screw Expansion, Orthodontic (All types of Orthodontic Retainer and Expansion Screw), Orthodontic Retraction Screws 2014 30
Retractor, All Types Class 1 Xihubiom, Retractor, Orthodontic (All types of orthodontic Retractors), Retractor, Orthodontic 2014 45
Tube, Orthodontic Class 1 Westlake, Tube, Orthodontic, Tube, Orthodontic (All type of Buccal Tube) 2014 34
Wire, Orthodontic Class 1 Westlake, Wire, Orthodontic (All type of NITI and Stainless Steel wire and Springs), Wire, Orthodontic 2014 43

From the Company

Published by the company on its own website, not by the FDA.

Information published by Hangzhou Westlake Biomaterial Co., Ltd.
Founded 1991
Main products Orthodontic brackets, Buccal tubes, Adhesives, Wires, Mini screws
Certifications FDA, RoHS
Export markets Multiple markets (15+ languages on website)
OEM and ODM Offered

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

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2,581device types they are registered for
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