BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

    Reg #: 1060818 · FEI: 1000592496 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Registration Number
    1060818
    FEI Number
    1000592496
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2300 RIVERCHASE CENTER
    City
    BIRMINGHAM
    State
    AL
    ZIP
    35244
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240531

    Owner / Operator

    Firm Name
    BIOHORIZONS IMPLANT SYSTEMS, INC.
    Operator Number
    9024113
    Address
    2300 RIVERCHASE CENTER, --
    City
    Birmingham
    State
    AL
    Postal Code
    35244
    Country
    US
    Correspondent
    Jared Cooper

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

    Establishment Types

    Manufacture Medical Device