Manufacturer registered with FDA
K-One MediTech Sdn. Bhd
Ipoh, Malaysia. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 29 registrations outside the US
- Establishments
- 1Malaysia
Registered in 2 markets
Where regulators' registries name K-One MediTech 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 | K-One MediTech Sdn. Bhd | 1 device types | — | Below |
| Malaysia | MDA | Registration holder | K-ONE MEDITECH SDN BHD | 9 | 2022–2025 | 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 K-One MediTech 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | — | 2018 |
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 |
|---|---|---|
| K-One MediTech Sdn. BhdFDA reg. 3014747754 | Ipoh Perak, Malaysia | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058595). 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.