BEUDAMED
    FDA Registration Active 🇺🇸 United States

    033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr

    Reg #: 3033781108 · FEI: 3033781108 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Straumann Manufacturing, Inc.
    Registration Number
    3033781108
    FEI Number
    3033781108
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    60 Minuteman Road
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122855

    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

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr 033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr 033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr 033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr 033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr 033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr 033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr 033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr 033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr 033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr 033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr 033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr 033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr 033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr 033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr 033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr 033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr 033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr

    Establishment Types

    Manufacture Medical Device