BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OverCEM SA Opaque

    Reg #: 3030648980 · FEI: 3030648980 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OVERFIBERS S.R.L
    Registration Number
    3030648980
    FEI Number
    3030648980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Malatesta, 7
    City
    IMOLA Bologna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K242366

    Owner / Operator

    Firm Name
    OVERFIBERS S.R.L
    Operator Number
    10092618
    Address
    Via Malatesta, 7
    City
    IMOLA
    State
    Bologna
    Postal Code
    40026
    Country
    IT
    Correspondent
    CASTRENZE GENOVESE

    US Agent

    Business Name
    Dental Plus USA LLC
    Contact Name
    Andrea Guzman
    Address
    1188 W 10400 S, Suite 2
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 6511378

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    OverCEM SA Opaque OverCEM SA Universal OverCEM SA Translucent OverCEM Cer-Abutment OverCEM Ti-Abutment

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198