Dental Device Guide
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Manufacturer registered with FDA

Shandong Huge Dental Material Corporation

Rizhao, China. Lists 15 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.

FDA owner/operator10031883Foreign exporterManufacturer4 clearances in five years
Device types listed
15
Brands and models
56
510(k) clearances
82016–2026
Markets registered in
12153 registrations outside the US
Establishments
1China
2016: 12017: 12019: 12020: 12022: 22026: 220102020

510(k) clearances per year, 2007–2026

Registered in 12 markets

Where regulators' registries name Shandong Huge Dental Material Corporation as the manufacturer or the registration holder of a device.

All markets
United States: 15 device types listedCanada: 56 registrationsEuropean Union: 32 registrationsUnited Kingdom: 21 registrationsAustralia: 12 registrationsTaiwan: 12 registrationsBrazil: 6 registrationsSouth Korea: 6 registrationsIsrael: 3 registrationsSaudi Arabia: 3 registrationsPeru: 1 registrationsSerbia: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerShandong Huge Dental Material Corporation8 clearances2016–2026Below
CanadaHealth CanadaRegistration holderSHANDONG HUGE DENTAL MATERIAL CORPORATION562012–2026Pure Global AI
European UnionEUDAMEDManufacturerShandong Huge Dental Material Corporation32—Pure Global AI
United KingdomMHRAManufacturerShandong Huge Dental Material Corporation21—Pure Global AI
AustraliaTGAManufacturerShandong Huge Dental Material Corporation122019–2026Pure Global AI
TaiwanTFDAManufacturerSHANDONG HUGE DENTAL MATERIAL CORPORATION122011–2024Pure Global AI
BrazilANVISAManufacturerSHANDONG HUGE DENTAL MATERIAL CORPORATION62018–2026Pure Global AI
South KoreaMFDSManufacturerShandong Huge Dental Material CorpShandong Huge Dental Material Corp.62010–2025Pure Global AI
IsraelAMARManufacturerShandong Huge Dental Material Corporation3—Pure Global AI
Saudi ArabiaSFDAManufacturerShandong Huge Dental Material Corporation3—Pure Global AI
PeruDIGEMIDManufacturerSHANDONG HUGE DENTAL MATERIAL CORPORATION12022–2022Pure Global AI
SerbiaALIMSManufacturerShandong Huge Dental Material Corporation12026–2026Pure 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 Shandong Huge Dental Material Corporation currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
BioTemps NOW Milling BlocksDenture BaseDenture Base PolymersFlexible BlockNOBILCAM PMMA DiscPMMA BLOCK
2021
Dental CementEMA · Class 2Dental cementsMaker
Glass Ionomer CementGlass Ionomer Cement (Filling)Glass Ionomer Cement (Luting)TopCEM Dual Cure Resin CementUltraCore Dual Cure Resin Cement
2016
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsMaker
BioTemps NOW Milling BlocksNOBILCAM PMMA DiscPMMA BLOCK
2021
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
Eternal Art Porcelain PowdersEternal Art Stain&Glaze Porcelain PowdersNOBILCAM Zirconia DiscZirconia Block
2014
Impression MaterialELW · Class 2Impression materialsMaker
A-Silicone for Bite RegistrationElastomeric Impression Material
2014
Resin Tooth Shade MaterialEBF · Class 2Dental compositesLister
TopCEM Dual Cure Resin CementUltraCore Dual Cure Resin Cement
2023
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
Dental ModelImpression TrayLight Curing TrayLower trayTray AdhesiveUpper trayWonder Light Cure Tray
2017
Shellac Base PlateEEA · Class 1—Maker
Try-in
2025
Intraoral Dental WaxEGD · Class 1—Maker
Casting Wax
2010
Preformed Impression TrayEHY · Class 1Impression traysMaker
Impression TrayLight Curing TrayLower trayUpper tray
2013
Restorative and Impression Material SyringeEID · Class 1Dental hand instrumentsMaker
DispenserDispensing gunMixerMixer & Oral tipsMixing tipsOral tips
2017
Alloy Other Noble MetalEJS · Class 2Dental alloysMaker
Firing Paste
2025
Teeth Plastic DentureELM · Class 2Denture resins & teethMaker
IMPLAKAIBIAO (MAIST)KAIFENG (Sonning)KAIJINGKAILIKAIPLUSKAITONG (Bluebell)NOBILDENTPrime DXLSelect XL
2 more
SeniorsSynthetic Polymer Teeth
2010
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Surgical Guide
2020
Sequential AlignerNXC · Class 2Clear alignersMaker
VinciSmile Invisible Orthodontic Appliance
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 Shandong Huge Dental Material Corporation as the applicant.

Decided510(k)DeviceDevice type
6 May 2026K260376Denture BaseEBI Rebasing Repairing Relining Denture Resin
9 Apr 2026K260067Eternal Art Porcelain PowdersEIH Porcelain Powder
12 Aug 2022K220680Denture Base PolymersEBI Rebasing Repairing Relining Denture Resin
4 Mar 2022K213994Flexible BlockEBI Rebasing Repairing Relining Denture Resin
24 Sep 2020K201684A-Silicone for Bite RegistrationELW Impression Material
18 Apr 2019K181747Orthodontic ApplianceNXC Sequential Aligner
3 Mar 2017K160345Glass Ionomer CementEMA Dental Cement
31 Oct 2016K161851Glass Ionomer Cement (Luting)EMA Dental Cement

Some of these clearances are listed with FDA today by another company: Hunan Vsmile Biotechnology Co.,Ltd (1).

Also lists devices cleared under other names

Shandong Huge Dental Material Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Rizhao Huge Dental Industry Co., Ltd. (2), Rizhao HuGe Biomaterials Company, Ltd. (1), Huge Dental Material Co., Ltd. (1), Rizhao Huge Dental Industry Co., Ltd. (1), Huge Dental Material Co., Ltd. (1).

Decided510(k)DeviceApplicantDevice type
22 Dec 2023K233082TopCEM Dual Cure Resin CementRizhao HuGe Biomaterials Company, Ltd.EBF Resin Tooth Shade Material
3 Nov 2020K201683PMMA BlockHuge Dental Material Co., Ltd.EBG Resin Temporary Crown and Bridge
9 Feb 2015K141421PMMA BLOCKRizhao Huge Dental Industry Co., Ltd.EBG Resin Temporary Crown and Bridge
27 Aug 2014K141162ALL-CERAMIC ZIRCONIA BLOCKRizhao Huge Dental Industry Co., Ltd.EIH Porcelain Powder
28 May 2014K133071ELASTIC IMPRESSION MATERIALRizhao Huge Dental Industry Co., Ltd.ELW Impression Material
16 Aug 2010K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHHuge Dental Material Co., Ltd.ELM Teeth Plastic Denture

Registered establishments

EstablishmentLocationWhat it does
Shandong Huge Dental Material CorporationFDA reg. 3008320092Rizhao Shandong, ChinaForeign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10031883). 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.