BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    OVERFIBERS S.R.L

    Reg #: 3030648980 · FEI: 3030648980 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    77
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    OVERFIBERS S.R.L
    Registration Number
    3030648980
    FEI Number
    3030648980
    Status
    Active
    Expiry Year
    2026
    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
    THEMA CORP
    Contact Name
    Silvia Tamarri
    Address
    2929 Arch Street
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US
    Email
    [email protected]
    Phone
    215 8459459

    Products

    Device Name Product Code
    Cement, Dental EMA
    Post, Root Canal ELR
    Drill, Dental, Intraoral DZA

    Proprietary Names

    OverCEM SA Universal OverCEM Ti-Abutment OverCEM SA Opaque OverCEM SA Translucent OverCEM Cer-Abutment Neobond Endodontic Over Post # 0 Hi-Rem Polygon Post # 2 Hi-Rem+ # 3 Hi-Rem Prosthetic Post # 0 Hi-Rem+ # 0 Polygon Over Post # 3 Duo Over Post # 1 Over Post+ # 0 Cylindrical Over Post # 0,8 Over Post+ # 2 Prosthetic Over Post # 4 Conical Over Post # Medium Polygon Over Post # 1 Hi-Rem Polygon Post # 1 Conical Over Post # Small Cylindrical Over Post Black # 0,8 Over Post+ # 1 Hi-Rem Polygon Post # 3 Endodontic Over Post # 3 Cylindrical Over Post # 1,2 Cylindrical Over Post # 1,6 Hi-Rem Prosthetic Post # 1 Hi-Rem Endodontic Post # 2 Cylindrical Over Post Black # 1,6 Conical Over Post # Large Over Post+ # 4 Endodontic Over Post # 2 Hi-Rem Endodontic Post # 3 Prosthetic Over Post # 1 Over Post+ # 3 Polygon Over Post # 2 Prosthetic Over Post # 3 Hi-Rem Prosthetic Post # 2 Cylindrical Over Post # 1,0 Hi-Rem Endodontic Post # 1 Cylindrical Over Post Black # 1,0 Endodontic Over Post # 4 Hi-Rem+ # 1 Duo Over Post # 2 Cylindrical Over Post Black # 1,4 Hi-Rem+ # 2 Cylindrical Over Post Black # 1,2 Cylindrical Over Post # 1,4 Endodontic Over Post # 1 Prosthetic Over Post # 2 Hi-Rem Prosthetic Post # 3 Prosthetic Over Post # 0 Cylindrical Drill # 1,2 Conical Drill # Large Prosthetic Drill # 0 H-Endodontic Drill # 1 Cylindrical Drill # 1,6 Cylindrical Drill # 0,8 Prosthetic Drill # 4 Prosthetic Drill # 1 Prosthetic Drill # 3 Conical Drill # Small Endontic Drill # 1 H-Endodontic Drill # 2 Endontic Drill # 3 H-Endodontic Drill # 3 Polygon Drill # 2 Conical Drill # Medium Cylindrical Drill # 1,4 Endontic Drill # 2 Cylindrical Drill # 1,0 Endontic Drill # 4 Polygon Drill # 1 Polygon Drill # 3 Prosthetic Drill # 2 Endontic Drill # 0

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device