Manufacturer registered with FDA
Hangzhou Westlake Biomaterial Co., Ltd.
Hangzhou, China. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 49
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6341 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Hangzhou Westlake Biomaterial Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hangzhou Westlake Biomaterial Co., Ltd. | 13 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Hangzhou Westlake Biomaterial Co.,Ltd. | 314 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HANGZHOU WESTLAKE BIOMATERIAL CO. LTDHANGZHOU WESTLAKE BIOMATERIAL CO., LTD | 10 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Hangzhou Westlake Biomaterial Co. Ltd | 8 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HANGZHOU WESTLAKE BIOMATERIAL CO., LTDHANGZHOU WESTLAKE BIOMATERIAL CO.,LTD · Hangzhou Westlake Biomaterial Co., Ltd. · +1 | 7 | 2013–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HANGZHOU WESTLAKE BIOMATERIAL CO., LTD. | 2 | 2024–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hangzhou Westlake Biomaterial Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | ORTHODONTIC RETRACTION SCREWSRetainer, Screw Expansion, OrthodonticRetainer, Screw Expansion, Orthodontic (All types of Orthodontic Retainer and Expansion Screw)XIHUBIOM | 2014 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Maintainer, Space Preformed, OrthodonticMaintainer, Space Preformed, Orthodontic (All types of Maintainers) | 2024 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | WestlakeWire, OrthodonticWire, Orthodontic (All type of NITI and Stainless Steel wire and Springs) | 2014 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Tube, OrthodonticTube, Orthodontic (All type of Buccal Tube)Westlake | 2014 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MirrorMirrors, Mouth, OrthodonticMirrors, Mouth, Orthodontic (All types of Orthodontic Mirror( Stainless and Glass)) | 2022 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Band, Elastic, OrthodonticBand, Elastic, Orthodontic (All types of orthodontic Elastic Bands, Power Chain, Sleeve, Thread, Seperator)Orthodontic Elastics | 2020 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Band, Preformed, OrthodonticBand, Preformed, Orthodontic (All types of orthodontic Stainless Steel bands)XIHUBIOM | 2014 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Archwire StopClamp, Wire, OrthodonticClamp, Wire, Orthodontic (Archwire Stop, Crimpable Hook, Lingual Button, Orthodontic Face Mask, Leapbar)Crimpable hookFACE MASKSLeapbarLingual buttonOrthodontic Face MaskORTHODONTIC LINGUAL BUTTON | 2022 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Instrument, Ligature Tucking, OrthodonticInstrument, Ligature Tucking, Orthodontic (All types of orthodontic Instruments)XIHUBIOM | 2014 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor, OrthodonticRetractor, Orthodontic (All types of orthodontic Retractors)XIHUBIOM | 2014 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Bracket, Metal, OrthodonticBracket, Metal, Orthodontic (All types of orthodontic Metal Bracket)CERAMIC BRACKETSMETAL BRACKETSOrthodontic BracketORTHODONTIC BRACKETSSAPPHIRE BRACKETSXIHUBIOM | 2014 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Plier, OrthodonticPlier, Orthodontic (All types of orthodontic pliers)XIHUBIOM | 2014 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, Implant, Dental, EndosseousAccessories, Implant, Dental, Endosseous (All types of Orthodontic Accessories, Implants) | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HANGZHOU WESTLAKE BIOMATERIAL CO., LTD.FDA reg. 3010669020 | Hangzhou Zhejiang, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045941). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.