BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Low Profile Abutment Non-Hexed Gold Cylinder

    Reg #: 1038806 · FEI: 1038806 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOMET 3i, LLC
    Registration Number
    1038806
    FEI Number
    1038806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4555 Riverside Drive
    City
    Palm Beach Gardens
    State
    FL
    ZIP
    33410
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092341

    Owner / Operator

    Firm Name
    Biomet 3i
    Operator Number
    1038806
    Address
    4555 Riverside Drive, --
    City
    Palm Beach Gardens
    State
    FL
    Postal Code
    33410
    Country
    US
    Correspondent
    Ruth Lopez

    Products

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

    Proprietary Names

    Low Profile Abutment Non-Hexed Gold Cylinder Low Profile Abutment Non-Hexed PreFormance Temporary Cylinder Low Profile Abutment Titanium Retaining Screw Low Profile Abutment Low Profile Abutment Gold-Tite Retaining Screw Low Profile Abutment QuickBridge Low Profile Abutment Healing Cap Low Profile Abutment Hexed Gold Cylinder Low Profile Abutment Non-Hexed Castable Cylinder Certain Low Profile One-Piece Abutment Low Profile Abutment Hexed Temporary Cylinder Low Profile Abutment QuickBridge Replacement Cap Certain Low Profile Abutment Low Profile Abutment Hexed PreFormance Temporary Cylinder Low Profile Abutment Hexed Castable Cylinder Low Profile Abutment Laser Weld Cylinder Low Profile Abutment Non-Hexed Temporary Cylinder Low Profile Abutment Distal Extension Low Profile One-Piece Abutment

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device