Dental Device Guide
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Not currently registered with FDA under this name

Normed Medizin-Technik GmbH

Arlington, VA, United States. Named as applicant on 1 dental 510(k) clearance between 1994 and 1994. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11994–1994
Markets registered in
549 registrations outside the US
Establishments
0—
1994: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 5 markets

Where regulators' registries name Normed Medizin-Technik GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 40 registrationsColombia: 7 registrationsAustralia: 1 registrationsIsrael: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNormed Medizin-Technik GmbH1 clearances1994–1994Below
South KoreaMFDSManufacturerNormed Medizin-Technik GmbHNORMED Medizin-Technik GmbH402000–2005Pure Global AI
ColombiaINVIMARegistration holderNORMED MEDIZIN- TECHNIK GMBH7—Pure Global AI
AustraliaTGAManufacturerNormed Medizin-Technik GmbH12007–2007Pure Global AI
IsraelAMARManufacturerNORMED MEDIZIN-TECHNIK 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 Normed Medizin-Technik GmbH as the applicant.

Decided510(k)DeviceDevice type
5 Jul 1994K931539NORMED TITANIUM MINIPLATE SYSTEMJEY Bone Plate

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.