Not currently registered with FDA under this name

Kuwotech Co., Ltd.

Anaheim, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2013 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12013–2013
Markets registered in
340 registrations outside the US
Establishments
0—
2013: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Kuwotech Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesEuropean Union: 35 registrationsAustralia: 5 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKuwotech Co., Ltd.1 clearances2013–2013Below
European UnionEUDAMEDManufacturerKUWOTECH35—Pure Global AI
AustraliaTGAManufacturerKuwotech Co Ltd52026–2026Pure 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

510(k) clearances

Clearances on which FDA names Kuwotech Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
26 Jul 2013K131117ZIRMON SERIESEIH Porcelain Powder

Sources

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 of the most recent filing, which can be a US agent.