Registered with FDA

TOP Corporation

ADACHI-KU, Japan. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator8030272Foreign exporterRepacker / relabeler
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
586 registrations outside the US
Establishments
1Japan

Registered in 5 markets

Where regulators' registries name TOP Corporation as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedTaiwan: 68 registrationsBrazil: 13 registrationsIsrael: 3 registrationsPeru: 2 registrations
RegisteredHome: JapanOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAListerTOP Corporation1 device types—Below
TaiwanTFDAManufacturerTOP CORPORATIONTOP Corporation681977–2024Pure Global AI
BrazilANVISAManufacturerTOP CORPORATION132018–2026Pure Global AI
IsraelAMARManufacturerTOP Corporation3—Pure Global AI
PeruDIGEMIDManufacturerTOP CORPORATION22026–2026Pure 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 TOP Corporation currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Patient Personal Hygiene KitNSB · Class 1—Lister
TOP Infection Protection Kit
2014

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

Registered establishments

EstablishmentLocationWhat it does
TOP CORPORATIONFDA reg. 9610993ADACHI-KU Tokyo, JapanForeign exporter, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8030272). 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.