Not currently registered with FDA under this name

Kohler Medizintechnik GmbH & Co. KG

Neuhausen, Germany. Named as applicant on 1 dental 510(k) clearance between 1998 and 1998. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11998–1998
Markets registered in
331 registrations outside the US
Establishments
0—
1998: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 3 markets

Where regulators' registries name Kohler Medizintechnik GmbH & Co. KG as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 30 registrationsTaiwan: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKohler Medizintechnik GmbH & Co. KG1 clearances1998–1998Below
South KoreaMFDSManufacturerKohler Medizintechnik GmbH & Co. KGkohler Medizintechnik GmbH & Co. KG · Kohler Medizintechnik GmbH & Co. KG.301999–2003Pure Global AI
TaiwanTFDAManufacturerKOHLER MEDIZINTECHNIK GMBH & CO. KG12012–2012Pure 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 Kohler Medizintechnik GmbH & Co. KG as the applicant.

Decided510(k)DeviceDevice type
30 Apr 1998K980616PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)EBI Rebasing Repairing Relining Denture Resin

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.