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Data / Medical devices / China / Shandong Huge Dental Material Corporation

Shandong Huge Dental Material Corporation: FDA-registered device maker in Rizhao Shandong, China, 15 510(k) clearances

Shandong Huge Dental Material Corporation is registered with the FDA (registration 3008320092) in Rizhao Shandong, China. It lists 17 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 6, 2026. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Shandong Huge Dental Material Corporation
FDA registration number
3008320092
Address
No. 68 Shanhai Road, Donggang District, Rizhao Shandong, China, 276800
Owner or operator
Shandong Huge Dental Material Corporation (10031883)
Roles
Exporter to the US, Manufacturer
First device listed
March 17, 2010
Registered through
2027
Brand names listed
A-Silicone for Bite Registration, BioTemps NOW Milling Blocks, Casting Wax, Dental Model, Denture Base, Denture Base Polymers, Dispenser, Dispensing gun and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Aligner, SequentialNXC2Manufactureraccessdata.fda.gov
Alloy, Other Noble MetalEJS2Manufactureraccessdata.fda.gov
Cement, DentalEMA2Exporter to the US, Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Denture, Plastic, TeethELM2Manufactureraccessdata.fda.gov
Hearing Aid, Air-Conduction, PrescriptionESD1Manufactureraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the USaccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufactureraccessdata.fda.gov
Plate, Base, ShellacEEA1Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 6, 2026K260376Denture BaseEBISubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
April 9, 2026K260067Eternal Art Porcelain PowdersEIHSubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
August 1, 2025K251252NOBILCAM IMPAK DiscMQCSubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
December 22, 2023K233082TopCEM Dual Cure Resin CementEBFSubstantially EquivalentRizhao Huge Biomaterials Company, Ltd.accessdata.fda.gov
August 12, 2022K220680Denture Base PolymersEBISubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
March 4, 2022K213994Flexible BlockEBISubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
November 3, 2020K201683PMMA BlockEBGSubstantially EquivalentHuge Dental Material Co., Ltd.accessdata.fda.gov
September 24, 2020K201684A-Silicone for Bite RegistrationELWSubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
April 18, 2019K181747Orthodontic ApplianceNXCSubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
March 3, 2017K160345Glass Ionomer CementEMASubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
October 31, 2016K161851Glass Ionomer Cement (Luting)EMASubstantially EquivalentShandong Huge Dental Material Corporationaccessdata.fda.gov
February 9, 2015K141421PMMA BLOCKEBGSubstantially EquivalentRizhao Huge Dental Industry Co., Ltd.accessdata.fda.gov
August 27, 2014K141162ALL-CERAMIC ZIRCONIA BLOCKEIHSubstantially EquivalentRizhao Huge Dental Industry Co., Ltd.accessdata.fda.gov
May 28, 2014K133071ELASTIC IMPRESSION MATERIALELWSubstantially EquivalentRizhao Huge Dental Industry Co., Ltd.accessdata.fda.gov
August 16, 2010K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHELMSubstantially EquivalentHuge Dental Material Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated May 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.