Manufacturer registered with FDA
Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD.
Guangzhou, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Onuge Personal Care(Guangdong)Manufacturer Group 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 | Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD. | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Onuge Personal Care（Guangdong）Manufacturer Group Co., LTD. | 3 | — | 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 Onuge Personal Care(Guangdong)Manufacturer Group 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 | Dentiguard LED Teeth whitening Kit | 2023 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | BocaBella Natural Teeth Whitening StripsBocaBella Teeth Whitening U-wrapsCharcoal Teeth Whitening StripsCVSHealth Brilliant White Whitening Strips(Coconut flavor)CVSHealth Brilliant White Whitening Strips(Peach flavor)Dissolving Teeth Whitening StripsFitreno Teeth Whitening Strips-ONG-YT-01Teeth Whitening Dry StripsTeeth Whitening Gel StripsTeeth Whitening Strips | 2022 |
| Dental Stain EraserMAU · Class 1 | — | Maker | BocaBella Natural Teeth Whitening StripsBocaBella Teeth Whitening U-wrapsCharcoal Teeth Whitening PowderDentiguard LED Teeth Whitening KitEEG Teeth Whitening KitEnlight Trading Inc.Teeth Whitening GelTeeth Whitening Gel 2ml/ 3ml/ 5ml /10mlTeeth Whitening Home KitTeeth Whitening Kit 4 moreTeeth Whitening PenTeeth Whitening Pen-TWP-01Teeth Whitening PowderTeeth Whitening System | 2020 |
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 |
|---|---|---|
| Onuge Personal Care (Guangdong) Manufacturer Group Co., LTD.FDA reg. 3010585908 | Guangzhou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062230). 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.