Not currently registered with FDA under this name

Concept, Inc.

Mchenry, IL, United States. Named as applicant on 1 dental 510(k) clearance between 1977 and 1977. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11977–1977
Markets registered in: 327 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1976–2026

Registered in 3 markets

Where regulators' registries name Concept, 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	Concept, Inc.	1 clearances	1977–1977	Below
Saudi Arabia	SFDA	Manufacturer	CO.N.CE.P.T. S.R.L.	22	—	Pure Global AI
Taiwan	TFDA	Manufacturer	CONCEPT, INC.	5	1980–1989	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 Concept, Inc. as the applicant.

Decided	510(k)	Device	Device type
3 Jan 1977	K761352	DENTAL STAIN REMOVER	EFW Manual Toothbrush

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.