Registered with FDA
New Prokin International Ltd
Zhongshan City, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name New Prokin International 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 | Lister | New Prokin International Ltd | 1 device types | — | Below |
| Australia | TGA | Manufacturer | New Prokin International Ltd | 1 | 2022–2022 | 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 New Prokin International 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 | Lister | TOOTHBRUSH, MANUAL | 2006 |
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 |
|---|---|---|
| NEW PROKIN INTERNATIONAL LTD.FDA reg. 3005613467 | Zhongshan City Guangdong, China | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9083480). 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.