Manufacturer registered with FDA

U&C International Co., Ltd.

Ansan-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10061784Manufacturer

Device types listed: 1
Brands and models: 9
510(k) clearances: 12019–2019
Markets registered in: 22 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name U&C International 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	Manufacturer	U&C International Co., Ltd.	1 clearances	2019–2019	Below
Brazil	ANVISA	Manufacturer	U&C INTERNATIONAL CO. LTD.	2	2023–2023	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

Devices listed with FDA

What U&C International Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	BlueToothChang's DA-vichChang's IrisEverestMegabio RainbowMegaPlusR2iCERazorU&C Liquid	2019

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names U&C International Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
11 Oct 2019	K191902	Razor, Everest, U&C Liquid	EIH Porcelain Powder

Some of these clearances are listed with FDA today by another company: IDS Korea (1).

Registered establishments

Establishment	Location	What it does
U&C INTERNATIONAL CO., LTD.FDA reg. 3015108415	Ansan-si Gyeonggi, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10061784). 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.