BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Cavitron

    Reg #: 3011944170 · FEI: 3011944170 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZAPALIGN INC.
    Registration Number
    3011944170
    FEI Number
    3011944170
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B-1001, U-space2, 670, Daewangpangyo-ro, Bundang-gu,
    City
    Seongnam-si, Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K970123

    Owner / Operator

    Firm Name
    Zapalign Inc.
    Operator Number
    10091758
    Address
    B-1001, U-space2, 670, Daewangpangyo-ro, Bundang-gu,
    City
    Seongnam-si,
    State
    Gyeonggi
    Postal Code
    13494
    Country
    KR
    Correspondent
    ByeongGeon Song

    US Agent

    Business Name
    Zapalign LLC
    Contact Name
    Marty Trabish
    Address
    2281 Griffin Rd
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33312
    Country
    US
    Email
    [email protected]
    Phone
    786 4793208

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC

    Proprietary Names

    Cavitron

    Establishment Types

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