BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Innovative BioCeramix, Inc

    Reg #: 3006313979 · FEI: 3006313979 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Innovative BioCeramix, Inc
    Registration Number
    3006313979
    FEI Number
    3006313979
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101 - 8218 North Fraser Way
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K130312

    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
    Syringe, Periodontic, Endodontic, Irrigating EIC

    Proprietary Names

    iRoot FM EndoSequence BC RRM 1.5G 2P EndoSequence BC RRM 1G 1P TotalFill BC RRM 1G 1P TotalFill BC Sealer 1.5G 1P EndoSequence BC Sealer HiFlow 1.5G 2P TotalFill BC Sealer 2G 1P EdgeBioceramic Sealer 2g EndoSequence BC Sealer HiFlow 1.5G 1P EndoSequence BC Sealer Trial Pack EdgeBioceramic ThermalFlow 1.5g EndoSequence BC Sealer 2G 1P EndoSequence BC Sealer 1.6G 2P TotalFill BC Sealer HiFlow 1.5G 1P BC Tips 15P EndoSequence BC RRM Putty 3G 1P EndoSequence BC RRM Putty .5G EdgeBioceramic RetroFill and Perforation Repair Material .5g TotalFill BC RRM Putty 2.5G 1P EndoSequence BC Pediatric Putty .5g 1P EndoSequence BC RRM Fast Set Putty 1P EndoSequence BC Pediatric Putty .5g 6P TotalFill BC RRM Fast Set Putty 1P

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device