BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV)

    Reg #: 1222802 · FEI: 1000120733 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DENTSPLY IH Inc.
    Registration Number
    1222802
    FEI Number
    1000120733
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    590 LINCOLN STREET
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130999

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Plus Implant (EV) Atlantis Abutment (Titanium) for Astra Tech OsseoSpeed Profile EV Atlantis Abutment in Zirconia for Astra Tech OsseoSpeed Profile EV

    Establishment Types

    Manufacture Medical Device