BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    LAB AIR Z HANDPIECE

    Reg #: 3002808149 · FEI: 3002808149 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHOFU INC.
    Registration Number
    3002808149
    FEI Number
    3002808149
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11 KAMITAKAMATSU-CHO
    City
    FUKUINE, HIGASHIYAMA-KU Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K962542

    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
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    LAB AIR Z HANDPIECE

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device