BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BIOLINE DENTAL IMPLANT SYSTEMS LTD

    Reg #: 3014329459 · FEI: 3014329459 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    BIOLINE DENTAL IMPLANT SYSTEMS LTD
    Registration Number
    3014329459
    FEI Number
    3014329459
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 Haella St Tefen Industrial Park POB 70
    City
    Migdal Tefen Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K250872

    Owner / Operator

    Firm Name
    Bioline Dental Implant Systems Ltd
    Operator Number
    10092547
    Address
    1 Haella St Tefen Industrial Park POB 70
    City
    Migdal Tefen
    State
    Northern
    Postal Code
    2495900
    Country
    IL

    US Agent

    Business Name
    Blackwell Device Consulting
    Contact Name
    Angela Blackwell
    Address
    16409 Se Division St Ste 216
    City
    Portland
    State
    OR
    ZIP
    97236
    Country
    US
    Email
    [email protected]
    Phone
    704 4509934

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Non-Irrigation Endosseous Dental Implant Drill Bits QRQ
    Instrument, Diamond, Dental DZP
    Bur, Dental EJL
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Bioline Dental Implant System Pterygoid Implants Drill Trephine Drill Guided Surgery Drill Drill Extension Zygomatic Implants Drill Cortical Drill Step Drill Countersink Drill FG Diamond Dental Burs FG Dental Burs Digital Analog Driver Hex Long Depth Probe Scan Body Scan Body for Conical Connection Slim Hex Driver Surgical Screw Driver Driver Hex Digital Analog for Slim Connection Torque Ratchet Driver Hex short Scan Body for Slim Connection

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device