BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    YAMAHACHI DENTAL MFG. CO.

    Reg #: 3020841418 · FEI: 3020841418 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    25
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    YAMAHACHI DENTAL MFG. CO.
    Registration Number
    3020841418
    FEI Number
    3020841418
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    54-1Ochigara, Nishiura-Cho
    City
    Gamagori City Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K254091

    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 Park Avenue
    City
    Nutley
    State
    NJ
    ZIP
    07110
    Country
    US
    Email
    [email protected]
    Phone
    973 3202909

    Products

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility