BEUDAMED
    FDA Registration Active 🇺🇸 United States

    J. MORITA USA, INC.

    Reg #: 2081055 · FEI: 2081055 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    J. MORITA USA, INC.
    Registration Number
    2081055
    FEI Number
    2081055
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9 MASON
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060844

    Owner / Operator

    Firm Name
    J. MORITA USA
    Operator Number
    8030247
    Address
    9 Mason
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Gutta-Percha EKM
    Bone Grafting Material, Synthetic LYC
    Unit, Operative Dental EIA
    Point, Paper, Endodontic EKN
    File, Pulp Canal, Endodontic EKS
    Post, Root Canal ELR
    Crown And Bridge, Temporary, Resin EBG
    Material, Impression ELW
    Zinc Oxide Eugenol EMB
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE
    Accessories, Retractor, Dental EIF

    Proprietary Names

    SilkLine Soft Denture Relining Material Foundation RootFlex GF Glass Fiber Post CB Temp Temporary Crown & Bridge Material Perfectim Systems CF Carbon Fiber Post Power Temp(TM) Temporary Cement FormCore DC Core Build-up Material Max Bond LC Self-etching Bonding Agent Free Access II Lip & Cheek Retractor

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility