BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    PreXolid Implant System

    Reg #: 3033519161 · FEI: 3033519161 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    8dent Inc.
    Registration Number
    3033519161
    FEI Number
    3033519161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20-13, Seogimhaesandan-ro
    City
    Gimhae-si Gyeongnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231426

    Owner / Operator

    Firm Name
    8dent Inc.
    Operator Number
    10091412
    Address
    20-13, Seogimhaesandan-ro
    City
    Gimhae-si
    State
    Gyeongnam
    Postal Code
    50967
    Country
    KR
    Correspondent
    Seunghoon Lee

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    PreXolid Implant System 8plant Implant System Add-on Implant System

    Establishment Types

    Manufacture Medical Device