BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UNIVERSAL OPAQUE

    Reg #: 2916735 · FEI: 2916735 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHOFU DENTAL CORP.
    Registration Number
    2916735
    FEI Number
    2916735
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1225 Stone Dr
    City
    SAN MARCOS
    State
    CA
    ZIP
    92078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131504

    Owner / Operator

    Firm Name
    SHOFU INC.
    Operator Number
    9056340
    Address
    11 KAMITAKAMATSU-CHO, FUKUINE, HIGASHIYAMA-KU
    City
    KYOTO
    State
    JP-26
    Postal Code
    605-0983
    Country
    JP

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    UNIVERSAL OPAQUE

    Establishment Types

    Repack or Relabel Medical Device