Manufacturer registered with FDA
Fitson Sdn Bhd
Johor Bahru, Malaysia. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1Malaysia
Registered in 3 markets
Where regulators' registries name Fitson 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 | Fitson Sdn Bhd | 2 device types | — | Below |
| Malaysia | MDA | Registration holder | FITSON SDN BHD | 1 | 2023–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | FITSON SDN BHD | 1 | 2019–2019 | 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 Fitson 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 |
|---|---|---|---|---|
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | — | 2009 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | Allegre Puericulture SASHegen Pte LtdLaboratoires PoliveNurnberg Gummi Babyartikel GmbH & Co. KgPigeon Singapore Pte Ltd | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Fitson Sdn Bhd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Philips Electronics UK Limited (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Jun 2009 | K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER, | Philips Electronics UK Limited | KKO Fluid-Filled Teething Ring |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FITSON SDN BHDFDA reg. 3004957421 | Senai Johor, Malaysia | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029016). 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.