Manufacturer registered with FDA
Pak Mane Brush Limited
Hong Kong, Hong Kong SAR China. Lists 3 dental device types with FDA across 2 registered establishments.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 2China, Malaysia
Registered in 2 markets
Where regulators' registries name Pak Mane Brush Limited 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 | Pak Mane Brush Limited | 3 device types | — | Below |
| Colombia | INVIMA | Manufacturer | PAK MANE BRUSH LIMITED | 2 | — | 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 Pak Mane Brush Limited 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 | — | 2013 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | — | 2015 |
| Battery-Powered Ionic ToothbrushMMD · Class 1 | Toothbrushes | Maker | — | 2015 |
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 |
|---|---|---|
| Pak Mane Brush (Malaysia) Sdn. Bhd.FDA reg. 3043535416 | Pasir Gudang Johor, Malaysia | Manufacturer |
| Pak Mane Plastic And Metal (Shen Zhen) Company LimitedFDA reg. 3012499628 | Shenzhen Guangdong, China | Manufacturer |
Other names on FDA records
Pak Mane Plastic And Metal (Shen Zhen) Company Limited · Pak Mane Brush (Malaysia) Sdn. Bhd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043952). 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.