BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Opelaser PRO II

    Reg #: 9611036 · FEI: 3002809599 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Registration Number
    9611036
    FEI Number
    3002809599
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-3-6, KOTOBASHI, SUMIDA-KU
    City
    TOKYO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120932

    Owner / Operator

    Firm Name
    THE YOSHIDA DENTAL MFG. CO., LTD.
    Operator Number
    8030214
    Address
    1-3-6, KOTOBASHI, SUMIDA-KU, --
    City
    TOKYO
    State
    JP-NOTA
    Postal Code
    130 8516
    Country
    JP

    US Agent

    Business Name
    Kamm & Associates
    Contact Name
    Daniel Kamm
    Address
    8870 Ravello Ct
    City
    Naples
    State
    FL
    ZIP
    34114
    Country
    US
    Email
    [email protected]
    Phone
    239 4171727

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Opelaser PRO II Opelaser Lite II

    Establishment Types

    Manufacture Medical Device