Not currently registered with FDA under this name

Fimet OY

Washington, DC, United States. Named as applicant on 1 dental 510(k) clearance between 1989 and 1989. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11989–1989
Markets registered in: 413 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 4 markets

Where regulators' registries name Fimet OY as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Fimet OY	1 clearances	1989–1989	Below
European Union	EUDAMED	Manufacturer	Fimet Oy	9	—	Pure Global AI
Australia	TGA	Manufacturer	Fimet Oy	2	2008–2009	Pure Global AI
South Korea	MFDS	Manufacturer	FIMET OY	2	2004–2005	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 Fimet OY as the applicant.

Decided	510(k)	Device	Device type
10 Feb 1989	K884830	DENTAL CHAIR F1	KLC Dental Chair with Operative 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.