Manufacturer registered with FDA
Cross Protection M Sdn. Bhd.
KLANG, Malaysia. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 431 registrations outside the US
- Establishments
- 1Malaysia
Registered in 4 markets
Where regulators' registries name Cross Protection M Sdn. Bhd. 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 | Cross Protection M Sdn. Bhd. | 1 device types | — | Below |
| Malaysia | MDA | Registration holder | CROSS PROTECTION (M) SDN BHD | 21 | 2021–2027 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CROSS PROTECTION (M) SDN. BHD.CROSS PROTECTION (M) SDN.BHD | 8 | 2011–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CROSS PROTECTION (M) SDN. BHD. | 2 | 2009–2015 | 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 Cross Protection M Sdn. Bhd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Cross Protection Saliva EjectorCross Protection Saliva Ejector Tip | 2011 |
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 |
|---|---|---|
| CROSS PROTECTION M SDN BHDFDA reg. 3008107579 | Klang Selangor, Malaysia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036184). 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.