BEUDAMED
    FDA Registration Active 🇨🇴 Colombia

    Portux CAD/CAM Disc

    Reg #: 3003794907 · FEI: 3003794907 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    NEW STETIC
    Registration Number
    3003794907
    FEI Number
    3003794907
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARRERA 53, NO. 50-09
    City
    GUARNE Antioquia
    Country
    CO

    Regulatory Submissions

    510(k) Number
    K192153

    Owner / Operator

    Firm Name
    NEW STETIC
    Operator Number
    9026802
    Address
    CARRERA 53, NO. 50-09
    City
    Guarne
    State
    Antioquia
    Postal Code
    054050
    Country
    CO

    US Agent

    Business Name
    CERAGROUP INDUSTRIES
    Contact Name
    Fred Rosenfield
    Address
    5600 NW 12TH AVE SUITE 304
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    954 6700208

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Mouthguard, Prescription MQC

    Proprietary Names

    Portux CAD/CAM Disc

    Establishment Types

    Manufacture Medical Device