Manufacturer registered with FDA
Yangzhou Xinhua Brushes CO., LTD.
YANGZHOU, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 2104 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Yangzhou Xinhua Brushes 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 | Yangzhou Xinhua Brushes CO., LTD. | 3 device types | — | Below |
| Colombia | INVIMA | Manufacturer | YANGZHOU XINHUA BRUSHES CO., LTDYANGZHOU XINHUA BRUSHES CO. LTD · YANGZHOU XINHUA BRUSHES., LTD | 104 | — | 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 Yangzhou Xinhua Brushes 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH | 2008 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental FlossDental Floss Pick | 2011 |
| Tongue ScraperLCN · Class 1 | — | Maker | TONGUE CLEANER | 2021 |
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 |
|---|---|---|
| YANGZHOU XINHUA BRUSHES CO., LTD.FDA reg. 3004516804 | YANGZHOU Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10026538). 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.