Manufacturer registered with FDA
Shenzhen Ruiyi Business Technology Co., Ltd.
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shenzhen Ruiyi Business 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 | Shenzhen Ruiyi Business Technology Co., Ltd. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD. | 3 | 2023–2025 | 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 Shenzhen Ruiyi Business 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 | TEETH WHITENING KIT: RP-TW16-2,RP-TW16,RP-TW32TEETH WHITENING PEN:RP-TWG3-4 | 2023 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | — | 2022 |
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 |
|---|---|---|
| SHENZHEN RUIYI BUSINESS TECHNOLOGY CO., LTD.FDA reg. 3021282523 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083379). 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.