Not currently registered with FDA under this name

Linvatec Biomaterials, Ltd.

Tampere, Finland. Named as applicant on 1 dental 510(k) clearance between 2004 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12004–2004
Markets registered in: 25 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Linvatec Biomaterials, Ltd. 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	Linvatec Biomaterials, Ltd.	1 clearances	2004–2004	Below
South Korea	MFDS	Manufacturer	Linvatec Biomaterials Ltd.Linvatec Biomaterials Ltd	5	2001–2005	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 Linvatec Biomaterials, Ltd. as the applicant.

Decided	510(k)	Device	Device type
8 Oct 2004	K042517	BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS	JEY 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.