BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Straumann Pre-Milled Abutment Blank for Medentika Holder

    Reg #: 1222315 · FEI: 1000121052 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Straumann USA, LLC
    Registration Number
    1222315
    FEI Number
    1000121052
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    60 MINUTEMAN RD.
    City
    ANDOVER
    State
    MA
    ZIP
    01810
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243478

    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
    Abutment, Implant, Dental, Endosseous NHA
    Dental Abutment Design Software For Dental Laboratory PNP

    Proprietary Names

    Straumann Pre-Milled Abutment Blank for Medentika Holder Neodent Titanium Block for Medentika Holder Straumann InLab Validated Workflow

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198