Not currently registered with FDA under this name

Nuxen S.R.L.

Buenos Aires, Argentina. Named as applicant on 2 dental 510(k) clearances between 2012 and 2012. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22012–2012
Markets registered in: 528 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Nuxen S.R.L. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: ArgentinaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Nuxen S.R.L.	2 clearances	2012–2012	Below
European Union	EUDAMED	Manufacturer	NUXEN SRL	14	—	Pure Global AI
Brazil	ANVISA	Manufacturer	NUXEN SRL	9	2012–2020	Pure Global AI
Serbia	ALIMS	Manufacturer	NUXEN S.R.L.	3	2021–2021	Pure Global AI
Colombia	INVIMA	Manufacturer	NUXEN S.R.L.	2	—	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 Nuxen S.R.L. as the applicant.

Decided	510(k)	Device	Device type
10 Apr 2012	K113608	DEFLEX	EBI Rebasing Repairing Relining Denture Resin
16 Mar 2012	K113788	DEFLEX ACRILATO	EBI Rebasing Repairing Relining Denture Resin

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.