Not currently registered with FDA under this name

Sylphar N.V.

Rome, Italy. Named as applicant on 2 dental 510(k) clearances between 2013 and 2014. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22013–2014
Markets registered in: 512 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Sylphar N.V. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: ItalyOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Sylphar N.V.	2 clearances	2013–2014	Below
European Union	EUDAMED	Manufacturer	Sylphar nv	7	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Sylphar NV	3	—	Pure Global AI
Serbia	ALIMS	Manufacturer	Sylphar NV	1	2025–2025	Pure Global AI
South Korea	MFDS	Manufacturer	Sylphar NV	1	2009–2009	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 Sylphar N.V. as the applicant.

Decided	510(k)	Device	Device type
14 Feb 2014	K132426	SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS	LBH Cavity Varnish
14 Jan 2013	K122708	REMESENSE FOR SENSITIVE TEETH	LBH Cavity Varnish

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.