Manufacturer registered with FDA
Shenzhen Kaiyan Medical Equipment Co., Ltd
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 3108 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Kaiyan Medical Equipment 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 Kaiyan Medical Equipment Co., Ltd | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SHENZHEN KAIYAN MEDICAL EQUIPMENT CO. LTD. | 57 | 2018–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Kaiyan Medical Equipment Co Ltd | 51 | 2016–2026 | 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 Kaiyan Medical Equipment 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 | Heat source for bleaching teethTeeth Whitening Device (Model: YT-11E) | 2021 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | BON CHARGE RED LIGHT TOOTHBRUSH | 2026 |
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 Kaiyan Medical Equipment Co., LtdFDA reg. 3011644607 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049428). 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.