BEUDAMED
    FDA Registration Active 🇨🇳 China

    Yamahachi Dental Material (Changshu) Co., Ltd.

    Reg #: 3006942327 · FEI: 3006942327 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    9

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    Registration Details

    Registration Name
    Yamahachi Dental Material (Changshu) Co., Ltd.
    Registration Number
    3006942327
    FEI Number
    3006942327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 8 Zhibei Road, Zhitang Town
    City
    Changshu city Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K060507

    Owner / Operator

    Firm Name
    Yamahachi Dental Mfg. Co.
    Operator Number
    10024459
    Address
    54-1Ochigara, Nishiura-Cho
    City
    Gamagori City
    State
    Aichi
    Postal Code
    443-0105
    Country
    JP
    Correspondent
    Shuhei Hirota

    US Agent

    Business Name
    Yamahachi Dental Products USA
    Contact Name
    Lawrence Greenwald
    Address
    160 ParkAvenue
    City
    Nutley
    State
    NJ
    ZIP
    07110
    Country
    US
    Email
    [email protected]
    Phone
    973 3202909

    Products

    Device Name Product Code
    Denture, Plastic, Teeth ELM
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Accessories, Implant, Dental, Endosseous NDP
    Wax, Dental, Intraoral EGD
    Coating, Filling Material, Resin EBD
    Crown And Bridge, Temporary, Resin EBG
    Clasp, Preformed EHP
    Material, Impression Tray, Resin EBH
    Crown, Preformed ELZ

    Proprietary Names

    Shade Guide Naperce Crown PX Soluut PX Efucera PX Efucera AC New Ace Flat AC BASIS FLOW II Weldenz TrinDy Surgical Guide Yamahachi Parafin Wax Bite Rim Sticks WAX DISK Crown NS Efucera NS Yamahachi Pink CAD/CAM Disk JUSTI PRODUCTS OEM DISK Basis Twin Cure Basis Hi Refine Bright Basis GLOSSY COAT Yamahachi PMMA Disks Light Resin Plate TrinDy Tray TrinDy Try-In

    Establishment Types

    Manufacture Medical Device