Not currently registered with FDA under this name

H.C. Starck Ceramics GmbH

Selb, Germany. Named as applicant on 3 dental 510(k) clearances between 2013 and 2015. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32013–2015
Markets registered in
21 registrations outside the US
Establishments
0—
2013: 12014: 12015: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name H.C. Starck Ceramics GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesCanada: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantH.C. Starck Ceramics GmbH3 clearances2013–2015Below
CanadaHealth CanadaRegistration holderH.C. STARCK CERAMICS GMBH CO. KG12009–2009Pure 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 H.C. Starck Ceramics GmbH as the applicant.

Decided510(k)DeviceDevice type
9 Jul 2015K143656StarCeram® Z-Nature, StarCeram® Z-SmileEIH Porcelain Powder
5 Jun 2014K140924STARCERAMEIH Porcelain Powder
5 Dec 2013K133213STARCERAMEIH 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.