Not currently registered with FDA under this name

Metoxit AG

Thayngen, Switzerland. Named as applicant on 2 dental 510(k) clearances between 2007 and 2018. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22007–2018
Markets registered in
414 registrations outside the US
Establishments
0—
2007: 12018: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 4 markets

Where regulators' registries name Metoxit AG as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesCanada: 9 registrationsTaiwan: 3 registrationsEuropean Union: 2 registrations
RegisteredHome: SwitzerlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMetoxit AG2 clearances2007–2018Below
CanadaHealth CanadaRegistration holderMETOXIT AG92008–2020Pure Global AI
TaiwanTFDAManufacturerMETOXIT AGMetoxit AG32009–2016Pure Global AI
European UnionEUDAMEDManufacturerMetoxit AG2—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

510(k) clearances

Clearances on which FDA names Metoxit AG as the applicant.

Decided510(k)DeviceDevice type
23 Aug 2018K170050Z-CAD smileEIH Porcelain Powder
31 Oct 2007K072569METOXIT CAM-BLANKSEIH 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.