Not currently registered with FDA under this name

Huge Dental Material Co., Ltd.

Rizhao City, China. Named as applicant on 1 dental 510(k) clearance between 2020 and 2020. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12020–2020
Markets registered in
25 registrations outside the US
Establishments
0—
2020: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

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

All markets
United States: 1 clearancesBrazil: 5 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantHuge Dental Material Co., Ltd.1 clearances2020–2020Below
BrazilANVISAManufacturerHuge Dental Material Co., Ltd.52013–2020Pure 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 Huge Dental Material Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
3 Nov 2020K201683PMMA BlockEBG Resin Temporary Crown and Bridge

Some of these clearances are listed with FDA today by another company: Shandong Huge Dental Material Corporation (1), Prismatik Dentalcraft, Inc. (1), MyoHealth Technologies, LLC (1), The Argen Corporation (1).

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.