Manufacturer registered with FDA
怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence Co.,Ltd
Kawasaki, Japan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Japan
Registered in 2 markets
Where regulators' registries name 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence 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 | 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence Co.,Ltd | 1 device types | — | Below |
| China | NMPA | Registration holder | 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence Co.,Ltd | 1 | — | 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 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence 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 | WE Light Class II | 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 |
|---|---|---|
| WHITE ESSENCE Co., LtdFDA reg. 3030670291 | Kawasaki-city Kanagawa, Japan | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090949). 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.