BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BLT 3.3mm NC, SLA 18mm, TiZr, Loxim

    Reg #: 9613348 · FEI: 3004975279 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INSTITUT STRAUMANN AG
    Registration Number
    9613348
    FEI Number
    3004975279
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PETER MERIAN-WEG 12
    City
    BASEL Basel-Stadt
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K153758

    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
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    BLT 3.3mm NC, SLA 18mm, TiZr, Loxim BLT 4.1 RC, SLActive 18mm, TiZr, Loxim BLT 4.1mm RC, SLA 18mm, TiZr, Loxim BLT 4.8 RC, SLActive 18mm, TiZr, Loxim BLT 3.3 NC, SLActive 18mm, TiZr, Loxim BLT 4.8mm RC, SLA 18mm, TiZr, Loxim

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility