BEUDAMED
    FDA Registration Active 🇨🇳 China

    Shandong Huge Dental Material Corporation

    Reg #: 3008320092 · FEI: 3008320092 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    50
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    Shandong Huge Dental Material Corporation
    Registration Number
    3008320092
    FEI Number
    3008320092
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 68 Shanhai Road, Donggang District
    City
    Rizhao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213994

    Owner / Operator

    Firm Name
    Shandong Huge Dental Material Corporation
    Operator Number
    10031883
    Address
    No. 68 Shanhai Road, Donggang District
    City
    Rizhao
    State
    Shandong
    Postal Code
    276800
    Country
    CN
    Correspondent
    Steven Song

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Denture, Plastic, Teeth ELM
    Material, Impression ELW
    Wax, Dental, Intraoral EGD
    Alloy, Other Noble Metal EJS
    Syringe, Restorative And Impression Material EID
    Crown And Bridge, Temporary, Resin EBG
    Tray, Impression, Preformed EHY
    Material, Impression Tray, Resin EBH
    Cement, Dental EMA
    Powder, Porcelain EIH
    Plate, Base, Shellac EEA
    Accessories, Implant, Dental, Endosseous NDP
    Hearing Aid, Air-Conduction, Prescription ESD
    Material, Tooth Shade, Resin EBF
    Aligner, Sequential NXC

    Proprietary Names

    Flexible Block Synthetic Polymer Teeth KAIJING Seniors IMPLA NOBILDENT KAILI KAIBIAO (MAIST) KAIFENG (Sonning) KAITONG (Bluebell) KAIPLUS Select XL Prime DXL Elastomeric Impression Material Casting Wax Firing Paste Oral tips Dispenser Dispensing gun Mixer Mixing tips Mixer & Oral tips BioTemps NOW Milling Blocks PMMA BLOCK Light Curing Tray Upper tray Impression Tray Lower tray Dental Model Wonder Light Cure Tray Tray Adhesive Glass Ionomer Cement (Luting) Glass Ionomer Cement Eternal Art Porcelain Powders Eternal Art Stain&Glaze Porcelain Powders Try-in Denture Base Polymers A-Silicone for Bite Registration Surgical Guide PERFIT Ear Impression Silicone TopCEM Dual Cure Resin Cement UltraCore Dual Cure Resin Cement VinciSmile Invisible Orthodontic Appliance Denture Base Glass Ionomer Cement (Filling) Zirconia Block NOBILCAM Zirconia Disc NOBILCAM PMMA Disc IMPAK Disc Milling Disc

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device