Manufacturer registered with FDA
Zhengzhou Huaer Electro-optics Technology Co., Ltd.
Zhengzhou, China. Lists 15 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 15
- Brands and models
- 37
- 510(k) clearances
- 12020–2020
- Markets registered in
- 838 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Zhengzhou Huaer Electro-optics Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Zhengzhou Huaer Electro-optics Technology Co., Ltd. | 1 clearances | 2020–2020 | Below |
| European Union | EUDAMED | Manufacturer | Zhengzhou Huaer Electro-optics Technology Co, Ltd. | 18 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Zhengzhou Huaer Electro-Optics Technology Co Ltd | 6 | 2017–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhengzhou Huaer Electro- Optics Technology Co., Ltd.Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO.,LTD. | 3 | 2015–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY | 1 | 2016–2016 | 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 Zhengzhou Huaer Electro-optics Technology 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Outie tool | 2024 |
| Resin Denture Hydrophilic CoatingEBE · Class 2 | — | Maker | resin material | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Ortho Model ResinVacuum Forming Material, Pro Guard Mouthguard Material, Pro-form Vacuum Forming Material, Pro- Tray Custom MaterialWater-Washable Ortho Model Resin3D printing Resin | 2021 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Chewies | 2024 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Heat Source for Bleaching TeethTeeth Whitening lamp/Machine/Light | 2012 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | water flosser | 2022 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Cleanser, Denture, Denture Cleanser, denture cleaning tablets | 2021 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Preformed impression tray, Plastic impression tray, impression tray | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor | 2019 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Impression material kitImpression Material, Elastomeric Impression Material, Light Body VPS Addition Silicone Elastomeric Impression Material | 2020 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Teeth Cleaning Kit | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric toothbrush | 2022 |
| Dental Stain EraserMAU · Class 1 | — | Maker | BlanQuest Home Whitening Kit GB-HOM101BlanQuest Pro Professional Whitening Treatment Kit GB-PRO101Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste,Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel,Enamel Care Serumgingival barriel, gum protectorGingival barrier/Gum protectorGloboDent Whitening Accelerator GB-GWA101Hyaluronic Gum SerumLuxBrite Personal Teeth Whitening System GB-LB101 8 moreLuxBrite Refill Kit GB-LX105Luxsmile/Selvra Teeth whitening liquid HR-BSG01Mouth Trayremineralization gel, oral spray, mouth trays, teeth cleaning and whitening foam, teeth whitening foam toothpaste,teeth whitening essence,teeth whitening serum, Teeth whitening gel, dual barrel syringe gel, professional whitening gel,Teeth whitening kit, teeth whitening home kit, teeth whitening system, teeth bleaching system, teeth bleaching kit,Teeth whitening powder, Teeth whitening strips, Teeth whitening pen, bleaching pen, teeth whitener,teeth whitening toner | 2015 |
| Plaque Disclosing KitNYH · Class 2 | — | Maker | Dental Plaque Indicator | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Zhengzhou Huaer Electro-optics Technology Co., Ltd. as the applicant.
Some of these clearances are listed with FDA today by another company: Sleepcare, LLC (1), GrindGuard Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZHENGZHOU HUAER ELECTRO-OPTICS TECHNOLOGY CO., LTD.FDA reg. 3008648418 | Zhengzhou Henan, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040158). 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.