Not currently registered with FDA under this name

C. Hafner GmbH & Co.

Chicago, IL, United States. Named as applicant on 1 dental 510(k) clearance between 1999 and 1999. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11999–1999
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name C. Hafner GmbH & Co. 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	C. Hafner GmbH & Co.	1 clearances	1999–1999	Below
Canada	Health Canada	Registration holder	C. HAFNER GMBH & COMPANY	1	1999–1999	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 C. Hafner GmbH & Co. as the applicant.

Decided	510(k)	Device	Device type
2 Apr 1999	K990670	HELIOFORM GOLD-BASED ALLOY	EJT Gold-Based Noble Metal Alloy

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.