Not currently registered with FDA under this name

Amdent AB

Nynashamn, Sweden. Named as applicant on 1 dental 510(k) clearance between 1993 and 1993. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11993–1993
Markets registered in: 28 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Amdent AB as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: SwedenOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Amdent AB	1 clearances	1993–1993	Below
South Korea	MFDS	Manufacturer	AMDENT ABAmdent AB	8	1999–2005	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 Amdent AB as the applicant.

Decided	510(k)	Device	Device type
20 Oct 1993	K920328	AMDENT 2030, POLISHER/SCALER	ELC Ultrasonic Scaler

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.