Not currently registered with FDA under this name

Alphadent Co., Ltd.

Seoul, South Korea. Named as applicant on 1 dental 510(k) clearance between 2006 and 2006. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12006–2006
Markets registered in: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Alphadent Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Alphadent Co., Ltd.	1 clearances	2006–2006	Below
Taiwan	TFDA	Manufacturer	ALPHADENT CO., LTD.	2	2017–2021	Pure Global AI
Brazil	ANVISA	Manufacturer	ALPHADENT	1	2011–2011	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 Alphadent Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
5 Sep 2006	K062504	CERAMAX	EIH Porcelain Powder

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.