Not currently registered with FDA under this name

Medicon, Inc.

D-78532/Tuttlingen, Germany. Named as applicant on 1 dental 510(k) clearance between 1995 and 1995. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11995–1995
Markets registered in
35 registrations outside the US
Establishments
0—
1995: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 3 markets

Where regulators' registries name Medicon, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 3 registrationsIndia: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMedicon, Inc.1 clearances1995–1995Below
South KoreaMFDSManufacturerMedicon32013–2014Pure Global AI
IndiaCDSCORegistration holderMEDICON22018–2025Pure 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 Medicon, Inc. as the applicant.

Decided510(k)DeviceDevice type
22 Jun 1995K952168TITANIUM MANDIBULAR FRACTURE 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.