Dental Device Guide
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Not currently registered with FDA under this name

Trinon Titanium GmbH

Karlsruhe, Germany. Named as applicant on 2 dental 510(k) clearances between 2012 and 2017. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22012–2017
Markets registered in
541 registrations outside the US
Establishments
0—
2012: 12017: 120102020

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Trinon Titanium GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesCanada: 26 registrationsSouth Korea: 8 registrationsTaiwan: 6 registrationsColombia: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantTrinon Titanium GmbH2 clearances2012–2017Below
CanadaHealth CanadaRegistration holderTRINON TITANIUM GMBH262012–2017Pure Global AI
South KoreaMFDSManufacturerTrinon Titanium GmbHTRINON Titanium GmbH82003–2006Pure Global AI
TaiwanTFDAManufacturerTRINON TITANIUM GMBH62005–2018Pure Global AI
ColombiaINVIMAManufacturerTRINON TITANIUM GMBH1—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 Trinon Titanium GmbH as the applicant.

Decided510(k)DeviceDevice type
3 May 2017K163640QZA and RS Dental Implant SystemsDZE Root-Form Endosseous Implant
3 Jul 2012K103577TRINON Q & Q3 IMPLANT SYSTEMDZE Root-Form Endosseous Implant

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.