Dental implant

  • 모델명 / 제조번호(시리얼번호)
    Model Number IFOA411, Lot # 2011111333, 2011111333-S1
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France.
  • 제품 설명
    Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. || Product provides 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

제조사

  • 제조사 주소
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 160 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    GemLock Long Hex Drivers - RHL2.5, lots 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456 and 62773158.
  • 제품 설명
    Dental implants are indicated in the treatment and rehabilitation of patients with tooth loss, partial or total.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    NobelSpeedy Shorty Implant, NobelSpeedy Shorty RP
  • Manufacturer
    N/A
  • 모델명 / 제조번호(시리얼번호)
    Model: multiple, Affected:
  • Manufacturer
하나 더 155 건 더