Not currently registered with FDA under this name

Global Top, Inc.

Seoul, South Korea. Named as applicant on 1 dental 510(k) clearance between 2008 and 2008. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12008–2008
Markets registered in
21 registrations outside the US
Establishments
0—
2008: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Global Top, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesTaiwan: 1 registrations
RegisteredHome: South KoreaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantGlobal Top, Inc.1 clearances2008–2008Below
TaiwanTFDAManufacturerGLOBAL TOP INC.12013–2013Pure 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 Global Top, Inc. as the applicant.

Decided510(k)DeviceDevice type
8 Aug 2008K081200DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4EIH 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.