BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    PMMA CAD/CAM disc

    Reg #: 1000243214 · FEI: 1000243214 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLIDENT d.o.o., Dental products industry
    Registration Number
    1000243214
    FEI Number
    1000243214
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VOLCJA DRAGA 42
    City
    VOLCJA DRAGA Rence-Vogrsko
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K112967

    Owner / Operator

    Firm Name
    Polident d.o.o.
    Operator Number
    9021465
    Address
    VOLCJA DRAGA 42, --
    City
    VOLCJA DRAGA
    State
    Rence-Vogrsko
    Postal Code
    5293
    Country
    SI
    Correspondent
    Beate - Pececnik

    US Agent

    Business Name
    AXSYS Inc
    Contact Name
    Steven M. Braykovich
    Address
    29627 W TECH DR
    City
    Wixom
    State
    MI
    ZIP
    48393
    Country
    US
    Email
    [email protected]
    Phone
    248 9268810

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    PMMA CAD/CAM disc DD poly Y ML

    Establishment Types

    Manufacture Medical Device