BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    ASIGA

    Reg #: 3024227208 · FEI: 3024227208 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    6

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    Registration Details

    Registration Name
    ASIGA
    Registration Number
    3024227208
    FEI Number
    3024227208
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Unit 2 19-21 Bourke Road,
    City
    Alexandria New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K243356

    Owner / Operator

    Firm Name
    Asiga
    Operator Number
    10085950
    Address
    Unit 2 19-21 Bourke Road,
    City
    Alexandria
    State
    New South Wales
    Postal Code
    2015
    Country
    AU
    Correspondent
    Joseph Azar

    US Agent

    Business Name
    Asiga America Inc.
    Contact Name
    Cory Lambertson
    Address
    1350 Highland Dr Ste F
    City
    Ann Arbor
    State
    MI
    ZIP
    48108
    Country
    US
    Email
    [email protected]
    Phone
    877 6899998

    Products

    Device Name Product Code
    Accessories, Implant, Dental, Endosseous NDP
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Indirect Bonding Tray QJJ
    Material, Impression Tray, Resin EBH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG

    Proprietary Names

    DentaTRY DentaGUIDE DentaTOOTH DentaIBT DentaTRAY DentaTRAY Orange DentaBASE

    Establishment Types

    Manufacture Medical Device