Not currently registered with FDA under this name

Leader Italia S.R.L.

Austin, TX, United States. Named as applicant on 2 dental 510(k) clearances between 2007 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22007–2012
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Leader Italia S.R.L. 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	Leader Italia S.R.L.	2 clearances	2007–2012	Below
South Korea	MFDS	Manufacturer	Leader Italia SrL	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 Leader Italia S.R.L. as the applicant.

Decided	510(k)	Device	Device type
5 Sep 2012	K120792	TIXOS IMPLANT SYSTEM	DZE Root-Form Endosseous Implant
28 Nov 2007	K062931	IMPLUS IMPLANT SYSTEM	DZE Root-Form Endosseous Implant

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.