Not currently registered with FDA under this name

W & H Dentalwerk

Burmoos, Austria. 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: 32 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 3 markets

Where regulators' registries name W & H Dentalwerk as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: AustriaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	W & H Dentalwerk	1 clearances	1998–1998	Below
Australia	TGA	Manufacturer	W & H Dentalwerk	1	2019–2019	Pure Global AI
Israel	AMAR	Manufacturer	W&H Dentalwerk GmbH	1	—	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 W & H Dentalwerk as the applicant.

Decided	510(k)	Device	Device type
22 Jan 1998	K972889	ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)	EBW Handpiece and Cord Foot Controller

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.