BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Straumann cerabone

    Reg #: 3014206569 · FEI: 3014206569 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BOTISS BIOMATERIALS GMBH
    Registration Number
    3014206569
    FEI Number
    3014206569
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hauptstrasse 28
    City
    Zossen Brandenburg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K173594

    Owner / Operator

    Firm Name
    botiss biomaterials GmbH
    Operator Number
    10058419
    Address
    Hauptstrasse 28
    City
    Zossen
    State
    Brandenburg
    Postal Code
    15806
    Country
    DE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Bone Grafting Material, Animal Source NPM

    Proprietary Names

    Straumann cerabone cerabone

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility