BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EK SA Implant

    Reg #: 2219920 · FEI: 2219920 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2219920
    FEI Number
    2219920
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    108 Lake Denmark Rd
    City
    Rockaway
    State
    NJ
    ZIP
    07866
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203360

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

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

    Proprietary Names

    EK SA Implant EK Healing Abutment EK NH Implant

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)