BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Straumann® PrefGel

    Reg #: 9612827 · FEI: 3002806508 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIORA AB
    Registration Number
    9612827
    FEI Number
    3002806508
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    MEDEON SCIENCE PARK
    City
    MALMO Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K063812

    Owner / Operator

    Firm Name
    INSTITUT STRAUMANN AG
    Operator Number
    9005052
    Address
    PETER MERIAN-WEG 12
    City
    BASEL
    State
    CH-NOTA
    Postal Code
    CH-4002
    Country
    CH
    Correspondent
    Andreas Petermann

    US Agent

    Business Name
    Straumann USA, LLC
    Contact Name
    Jennifer M. Jackson
    Address
    60 Minuteman Road
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 7472509

    Products

    Device Name Product Code
    Cleanser, Root Canal KJJ

    Proprietary Names

    Straumann® PrefGel

    Establishment Types

    Manufacture Medical Device