BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Straumann Manufacturing, Inc.

    Reg #: 3024185724 · FEI: 3024185724 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    80
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Straumann Manufacturing, Inc.
    Registration Number
    3024185724
    FEI Number
    3024185724
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1961 Heritage Parkway
    City
    Mansfield
    State
    TX
    ZIP
    76063
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041295

    Owner / Operator

    Firm Name
    INSTITUT STRAUMANN AG
    Operator Number
    9005052
    Address
    PETER MERIAN-WEG 12
    City
    BASEL
    State
    CH-NOTA
    Postal Code
    CH-4002
    Country
    CH

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Alloy, Metal, Base EJH
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Crown And Bridge, Temporary, Resin EBG
    Powder, Porcelain EIH
    Dental Abutment Design Software For Dental Laboratory PNP
    Driver, Wire, And Bone Drill, Manual DZJ
    System, Image Processing, Radiological LLZ
    Material, Tooth Shade, Resin EBF
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN STRAUMANN DENTAL IMPLANT SYSTEM ticon and coron restorations Straumann CARES Screw-Retained Bridge and Dolder Bar Neodent Implant System – Helix Short Implant System Dental Implant Accesories Neodent Implant System - GM Line Medentika PreFace CAD/CAM Abutments Medentika TiBase CAD/CAM Abutments Medentika Abutment Screws Straumann CARES Abutments Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS polycon ae restoration zerion HT elements zerion and glass ceramic restorations Straumann Custom Abutment AS Neodent Implant System – GM Zygomatic Implant System Preface abutment Multi-unit TitaniumBase & Multi-unit Titanium Cap Titanium base 2nd generation TI-Forms abutment Titanium base ASC Flex MedentiBase Titaniumbase abutment Custom Abutment AS Straumann® CARES® Golden Ti/TiN Abutments Neodent Implant System - GM Helix LG Implants SRBB Bone Level Titamax CM Neodent Implant System Surgical Guide with Cut Profile coDiagnostiX Straumann Screw Retained Abutments Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments Straumann Variobase for Crown AS Roxolid BLX Implants polyamide restoration CARES TAN Abutment Straumann CARES TAN Abutment CARES® Advanced Bar CARES® Basic Bar CARES® Complex Bar Neodent Implant System - GM Helix 7 Straumann CARES Screw-Retained Bridges and Bars Strauamnn CARES Dolder Bar Titanium Straumann CARES Screw-retained Bridge Titanium Neodent Implant System - Temporary Abutments Neodent Custom Abutments AS Ti, ASC Screws Straumann Dental Implant System Porcelain powder Neodent Implant System - Zirconia Implant System Medentika TiBase 3.5 mm CAD/CAM Abutments n!ce Crown n!ce Inlay n!ce Partial Crown n!ce Veneer n!ce Onlay Medentika Custom Abutments Gold Hue Neodent Gold Hue Custom Abutments Neodent Implant System - GM Narrow Implant System TLX Implant System NC Variobase™ Abutments, with screw, D 3.8mm, H 3.5mm, TAN NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN NNC Variobase™ Abutments, with screw, D 3.9mm, H 3.75mm, TAN RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN WN Variobase™ Abutments, with screw, D 7mm, H 4.5mm, TAN RC Variobase™ Abutments, with screw, D 4.5mm, 3.5mm, TAN WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN RN Variobase™ Abutments, with screw, D 55mm, H 4mm, TAN NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN Straumann Variobase Abutments Straumann CARES CS2 Scanner CARES Abutment Neodent Implant System - Zygomatic Implants and Abutments Neodent Implant System - Mini Abutment 60 Neodent Implant System - GM Titanium Base for Bridge

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device