Not currently registered with FDA under this name

Orion Corporation Soredex

Helsinki, Finland. Named as applicant on 2 dental 510(k) clearances 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
21998–1998
Markets registered in
26 registrations outside the US
Establishments
0—
1998: 21990200020102020

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Orion Corporation Soredex as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesSouth Korea: 6 registrations
RegisteredHome: FinlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantOrion Corporation Soredex2 clearances1998–1998Below
South KoreaMFDSManufacturerORION CORPORATION, SOREDEXORION CORPORATION SOREDEX61999–2000Pure 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 Orion Corporation Soredex as the applicant.

Decided510(k)DeviceDevice type
30 Dec 1998K983267DIGORA FOR WINDOWS 2.0MUH Digital Extraoral Source X-Ray System
27 Mar 1998K974877CRANEX TOME CEPH, OR CRANEX TOMEEHD Extraoral with Timer X-Ray Unit

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.