BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nobel ™ Replace Compatible 3.5 mm

    Reg #: 3010145797 · FEI: 3010145797 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Contour Healer
    Registration Number
    3010145797
    FEI Number
    3010145797
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    609 Linkhorn Drive
    City
    Virginia Beach
    State
    VA
    ZIP
    23451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112099

    Owner / Operator

    Firm Name
    Contour Healer, LLC
    Operator Number
    10043159
    Address
    609 Linkhorn Drive
    City
    Virginia Beach
    State
    VA
    Postal Code
    23451
    Country
    US
    Correspondent
    Allen H White

    Products

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

    Proprietary Names

    Nobel ™ Replace Compatible 3.5 mm Hiossen Standard Connection Compatible Biomet 3i ™ Compatible 4 mm Nobel ™ Replace Compatible 5 mm Biomet 3i ™ Compatible 5 mm Nobel ™ Replace Compatible 4.3 mm Zimmer ™ /BioHorizons ™ Compatible 3.5 mm Zimmer ™ /BioHorizons ™ Compatible 5.7 mm Straumann Bone Level Compatible Nobel ™ Conical Connection Compatible 3.5 mm Nobel ™ Conical Connection Compatible 4.3/5 mm Zimmer ™ /BioHorizons ™ Compatible 4.5 mm

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility