BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BICON, LLC

    Reg #: 1223843 · FEI: 1000305589 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    42
    Establishment Types
    4
    Classifications
    18

    Registration Details

    Registration Name
    BICON, LLC
    Registration Number
    1223843
    FEI Number
    1000305589
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    501 Arborway
    City
    Boston
    State
    MA
    ZIP
    02130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K972417

    Owner / Operator

    Firm Name
    Bicon, LLC
    Operator Number
    9010847
    Address
    501 Arborway, --
    City
    Boston
    State
    MA
    Postal Code
    02130
    Country
    US
    Correspondent
    VINCENT J MORGAN

    Products

    Device Name Product Code
    Wheel, Polishing Agent EJQ
    Implant, Endosseous, Root-Form DZE
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Chisel, Osteotome, Surgical EMM
    Material, Impression Tray, Resin EBH
    Handpiece, Direct Drive, Ac-Powered EKX
    Cleanser, Root Canal KJJ
    Instruments, Dental Hand DZN
    Bone Grafting Material, Synthetic LYC
    Tray, Surgical, Instrument FSM
    Material, Tooth Shade, Resin EBF
    Accessories, Implant, Dental, Endosseous NDP
    Crown And Bridge, Temporary, Resin EBG
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Bur, Dental EJL
    Gauge, Depth, Instrument, Dental EIL
    Abutment, Implant, Dental, Endosseous NHA
    Chisel, Bone, Surgical EML

    Proprietary Names

    Polishing Kit IAC 6 x 8mm Implant WI-75 E/KM Original Bicon Dental Implant Syste Osteotome Hydroplastic Resin AEU-26BIC HybenX 4.5mm Implants - 8,11,14mm Lengths Bicon Implant Integra-Ti Integra-CP Tissue Punches Sulcus Reamer Chisel Hand Reamer Seating Tip Bone Expander SynthoGraft 6 x 5.7mm Implant System Impulsion 4.5mm Guided Surgical Tray 5mm Guided Surgical Tray Comprehensive Instrumentation Tray 3mm Guided Surgical Tray 4mm Guided Surgical Tray Advanced Instrumentation Tray Restorative Instrumentation Tray TRINIA 5mm SHORT Implants Brevis Components Fixed-Detachable Components Locator Components Impression Copings Analogs Pilot Drill Latch Reamer Gauges 3mm Narrow Bicon Implant System MAX 2.5 Implant System 5 x 6mm Implant System 4.5 x 6mm and 6 x 6mm Implant

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device