Not currently registered with FDA under this name

Angiosystems, Inc.

Great Neck, NY, United States. Named as applicant on 1 dental 510(k) clearance between 1991 and 1991. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11991–1991
Markets registered in: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 3 markets

Where regulators' registries name Angiosystems, Inc. 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	Angiosystems, Inc.	1 clearances	1991–1991	Below
United Kingdom	MHRA	Manufacturer	AngioSystems, Inc	2	—	Pure Global AI
South Korea	MFDS	Manufacturer	AngioSystems	1	2022–2022	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 Angiosystems, Inc. as the applicant.

Decided	510(k)	Device	Device type
5 Mar 1991	K905461	PROCEDURE KIT/ROUTINE DENTAL PROCEDURES	EKS Endodontic Pulp Canal File

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.