Not currently registered with FDA under this name

Dentsply Gendex

Des Plaines, IL, United States. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12003–2003
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 Dentsply Gendex 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	Dentsply Gendex	1 clearances	2003–2003	Below
South Korea	MFDS	Manufacturer	DENTSPLY Gendex	1	2002–2002	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 Dentsply Gendex as the applicant.

Decided	510(k)	Device	Device type
25 Sep 2003	K032355	ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW	EHD Extraoral with Timer X-Ray Unit

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.