Not currently registered with FDA under this name

Dror Orthodesign , Ltd.

Jerusalem, Israel. Named as applicant on 2 dental 510(k) clearances between 2020 and 2026. No establishment is registered with FDA under this exact name today.

1 clearance in five years

Device types listed: 0
Brands and models: 0
510(k) clearances: 22020–2026
Markets registered in: 22 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Dror Orthodesign , Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: IsraelOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Dror Orthodesign , Ltd.	2 clearances	2020–2026	Below
Israel	AMAR	Manufacturer	Dror-Orthodesign Ltd.Dror Orthodesign Ltd.	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 Dror Orthodesign , Ltd. as the applicant.

Decided	510(k)	Device	Device type
3 Feb 2026	K253282	ZSmile System	NXC Sequential Aligner
6 May 2020	K192069	Aerodentis System	NXC Sequential Aligner

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.