Not currently registered with FDA under this name

Orion Diagnostica, Inc.

02101 Espoo, Finland. Named as applicant on 1 dental 510(k) clearance between 1992 and 1992. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11992–1992
Markets registered in: 678 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 6 markets

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

All markets

RegisteredHome: FinlandOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Orion Diagnostica, Inc.	1 clearances	1992–1992	Below
Canada	Health Canada	Registration holder	ORION DIAGNOSTICA OY	43	1999–2006	Pure Global AI
Colombia	INVIMA	Registration holder	ORION DIAGNOSTICA OY	28	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Orion Diagnostica Oy	3	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ORION DIAGNOSTICA OY	3	2005–2005	Pure Global AI
South Korea	MFDS	Manufacturer	Orion Diagnostica Oy	1	2011–2011	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 Orion Diagnostica, Inc. as the applicant.

Decided	510(k)	Device	Device type
2 Sep 1992	K914892	SALIVA-STIM	EGD Intraoral Dental Wax

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.