Not currently registered with FDA under this name

Engle Dental Systems

Forest Grove, OR, United States. Named as applicant on 1 dental 510(k) clearance between 1998 and 1998. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11998–1998
Markets registered in: 228 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Engle Dental Systems 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	Engle Dental Systems	1 clearances	1998–1998	Below
Canada	Health Canada	Registration holder	ENGLE DENTAL SYSTEMS, LLC	28	2023–2023	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 Engle Dental Systems as the applicant.

Decided	510(k)	Device	Device type
4 Nov 1998	K983285	ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS	EIA Operative Dental 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.