Osseotite Tapered Certain Implant

  • Model / Serial
    Model # INT510, Lot # 2011090751
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including PA, GA, OR, KS, NY, VA, CT, NH, IL, OK, and MA and internationally to Australia, Brazil, Columbia, France, Germany, Ireland, Italy, Japan, Paraguay, Portugal, and Spain.
  • Product Description
    Osseotite Tapered Certain Implant 5 X 10mm Model INT510 || Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
  • Product Description
    OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. || Dental Implants.
  • Manufacturer
  • Model / Serial
    Product: INT510; Lot #: 2011090751
  • Product Description
    Dental Implant, endosseous
  • Manufacturer
  • Model / Serial
    Lot Number 2011110798
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, UK, France, Canada, Mexico, Poland, Lebanon and Hong Kong.
  • Product Description
    ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. || Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
  • Manufacturer
  • Model / Serial
    Lot number: 2009110838.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, FL, GA, NC, NJ, NY, SC and the countries of Canada, Europe, Japan, and South America.
  • Product Description
    ***REF IOSS413*** OSSEIOTITE Certain Implant 4 x 13mm*** Sterile using Radiation*** Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain*** || Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
  • Manufacturer