Manufacturer registered with FDA
Jiangxi Royall Smart Technology Co., Ltd.
Ganzhou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Jiangxi Royall Smart 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 | Jiangxi Royall Smart Technology Co., Ltd. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | JIANGXI ROYALL SMART TECHNOLOGY CO., LTD. | 1 | 2025–2025 | 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 Jiangxi Royall Smart 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Oral Irrigator (Model: C2, C5, C6)Water flosser (model: CL1, CL2, CL1(W), CL2(W)) | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Sonic Electric Toothbrush (model: YM3(W))Sonic Electric Toothbrush (model: YM3)Sonic Electric Toothbrush (model: YM502(W), YM502(B), YM502(E), TBM10T, TBM11T, LY-T01)Sonic Electric Toothbrush (model: YM6(W), YM6(B), YM6(E), YM6Pro(W), YM6Pro(B), YM6Pro(E)) | 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 |
|---|---|---|
| JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.FDA reg. 3026164517 | Ganzhou Jiangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086681). 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.