Not currently registered with FDA under this name

Remedent NV

Claremont, NH, United States. Named as applicant on 2 dental 510(k) clearances between 2003 and 2009. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22003–2009
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 Remedent NV 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	Remedent NV	2 clearances	2003–2009	Below
South Korea	MFDS	Manufacturer	Remedent N.V.	1	2005–2005	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 Remedent NV as the applicant.

Decided	510(k)	Device	Device type
19 Mar 2009	K082594	REMESENSE	LBH Cavity Varnish
9 Jan 2003	K023652	REMECURE MODEL CL 15E	EBZ Ultraviolet Activator for Polymerization

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.