Manufacturer registered with FDA

Doctus Global

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

FDA owner/operator10089956Manufacturer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12023–2023
Markets registered in
1United States
Establishments
1South Korea
2023: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Doctus Global currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
Easy On Universal Glaze & Stain
2024

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 Doctus Global as the applicant.

Decided510(k)DeviceDevice type
30 Jun 2023K231264Easy On Universal Glaze & StainEIH Porcelain Powder

Registered establishments

EstablishmentLocationWhat it does
DOCTUS GLOBALFDA reg. 3030464310Goyang-si, Gyeonggi-do, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10089956). 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.