BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    EndoSequence BC Sealer 2G 1P

    Reg #: 3006313979 · FEI: 3006313979 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Innovative BioCeramix, Inc
    Registration Number
    3006313979
    FEI Number
    3006313979
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 - 8218 North Fraser Way
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K080917

    Owner / Operator

    Firm Name
    INNOVATIVE BIOCERAMIX INC.
    Operator Number
    9089383
    Address
    101 - 8218 North Fraser Way, --
    City
    Burnaby
    State
    British Columbia
    Postal Code
    V3N 0E9
    Country
    CA
    Correspondent
    QUANZU - YANG

    US Agent

    Business Name
    USDeviceAgent.com
    Contact Name
    Jim MacNee
    Address
    31574 Flying Cloud Drive
    City
    Laguna Niguel
    State
    CA
    ZIP
    92677
    Country
    US
    Email
    [email protected]
    Phone
    951 8486626

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    EndoSequence BC Sealer 2G 1P TotalFill BC Sealer 2G 1P EndoSequence BC Sealer HiFlow 1.5G 1P EdgeBioceramic ThermalFlow 1.5g EndoSequence BC Sealer Trial Pack EdgeBioceramic Sealer 2g TotalFill BC Sealer 1.5G 1P EndoSequence BC Sealer 1.6G 2P EndoSequence BC Sealer HiFlow 1.5G 2P TotalFill BC Sealer HiFlow 1.5G 1P

    Establishment Types

    Manufacture Medical Device