BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Certain Standard Abutment

    Reg #: 1038806 · FEI: 1038806 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    75
    Establishment Types
    1
    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
    K072642

    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

    Certain Standard Abutment IOL Distal Extension EP Healing Abutment Healing Abutment Certain Provide Abutment UCLA Titanium Non-Hexed Abutment Cylinder Conical Abutment Abutment Post Certain IOL Abutment Pre-Angled Abutment Gold-Tite Hexed Retaining Screw Certain EP Healing Abutment Certain Titanium Hexed Screw IOL Healing Cap Temporary Cylinder with Hexed Screw IOL Gold Cylinder Temporary Healing Cylinder Certain Straight Healing Abutment Conical Healing Cap EP Healing Abutment Gold-Tite Hexed UniScrew Chamfered Gold Cylinder for Standard Abutment Standard Abutment Castable Plastic Cylinder UCLA Gold Hexed Abutment Cylinder Certain UCLA Gold Hexed Abutment Cylinder Certain UCLA Gold Non-Hexed Abutment Cylinder Gold-Tite Square UniScrew Certain UCLA Gold Non-Hexed Cylinder UCLA Gold Non-Hexed Abutment Temporary Hexed Implant Cylinder with Hexed Screw Conical Gold Cylinder Hexed Temporary Cylinder Implant Temporary Hexed Cylinder with Hex Screw Titanium Hexed UniScrew GingiHue Post Certain UCLA Gold Non-Hexed Abutment UCLA Gold MicroMini Hexed Abutment Cylinder IOL Titanium Temporary Cylinder Standard Abutment Temporary Screw Conical Temporary Cylinder Non-Hexed Certain BellaTek Encode Healing Abutment GingiHue Pre-Angled Post Certain UCLA Gold Hexed Abutment Two piece EP Healing Abutment Conical Gold Cylinder Non-Hexed Conical Castable Cylinder Non-Hexed Certain Conical Abutment Certain GingiHue Post Certain Temporary Non-Hexed Cylinder Standard Abutment Gold Cylinder Conical EP Temporary Cylinder Non-Hexed UCLA Gold Non-Hexed Abutment Cylinder IOL Abutment and Screw Certain ZiReal POST Gold-Tite Hexed Abutment Screw Temporary Cylinder - Standard Abutment Temporary Non-Hexed Cylinder With Retention BellaTek Encode Healing Abutment Certain Gold-Tite Hexed Screw Standard Abutment Titanium Square UniScrew Conical Titanium Cylinder Non-Hexed Certain Conical Abutment Screw UCLA Gold Abutment Hexed Cylinder Temporary Hexed Cylinder with Retention Conical Temporary Cylinder Hexed UCLA Gold Standard ZR Hexed Abutment Cylinder Temporary Non-Hexed Implant Cylinder with Hexed Screw Conical EP Healing Cap UCLA Gold Abutment Non-Hexed Cylinder Certain UCLA Titanium Non-Hexed Abutment Conical Castable Cylinder Hexed Implant Temporary Non-Hexed Cylinder with Hex Screw Certain Temporary Hexed Cylinder Conical Abutment Gold Standard ZR Conical EP Temporary Cylinder Hexed

    Establishment Types

    Manufacture Medical Device