Manufacturer registered with FDA
Heyuan Hey White Technology Co., Ltd.
Heyuan, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Heyuan Hey White 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 | Heyuan Hey White Technology Co., Ltd. | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | Heyuan Hey White Technology Co., Ltd. | 1 | 2020–2020 | 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 Heyuan Hey White 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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Oral Device YLX-307i, Teeth Whitening Device, Teeth Whitening Vibration DeviceRed Light Therapy Device | 2019 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Children toothbrushFinger brush | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Anti-snore mouth guardMouth Tray; Tray Case | 2019 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Gum health serumGum protector | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | check retractor | 2019 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Professional Shade Guide | 2019 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Light therapy toothbrushOptical Whitening Toothbrush | 2019 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Bib | 2019 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Dentifrice kits, teeth whitening penPurple color corrector whitening gelTeeth Whitening Kit, Teeth Whitening Gel, Charcoal Teeth Whitening Powder,Teeth Whitening Strips; Ionic teeth whitening device | 2019 |
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 |
|---|---|---|
| HEYUAN HEY WHITE TECHNOLOGY CO., LTD.FDA reg. 3015287618 | Heyuan Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059803). 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.