Not currently registered with FDA under this name

Ceramay GmbH & Co.Kg

Ayer, MA, United States. Named as applicant on 1 dental 510(k) clearance between 2015 and 2015. No establishment is registered with FDA under this exact name today.

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

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Ceramay GmbH & Co.Kg as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 4 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantCeramay GmbH & Co.Kg1 clearances2015–2015Below
South KoreaMFDSManufacturerCeramay GmbH & Co. KGCeramay GmbH & Co.KG42003–2015Pure 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 Ceramay GmbH & Co.Kg as the applicant.

Decided510(k)DeviceDevice type
28 Jan 2015K141400DCCERAM SYSTEMEIH 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.