PROVIDE PROTECTION CAP

  • Model / Serial
    Model Number: PPC484, Lot Numbers: 970773, 977566, 987984, 1003033, 1038519, 1038520, 1045556, 1046268, 1054540, 1059416, 1059512, 1065495, 1065497, 1071762, 1071763, 1073161, 1073163, 1108328, 1128077, 1139601, 1141281, 1141282, 1150838, 1153463, 1165800, 1167709, 1171489, 1172858, 1173629, 1179005, 1183068, 1184510.  Model Number: PPC485, Lot Numbers: 1071764, 1071765, 1118826, 1143159, 1171487, 1178795, 1179690.   Model Number PPC654, Lot Numbers: 977565, 987983, 1004138, 1009002, 1032456, 1033485, 1034852, 1035364, 1053562, 1053563, 1053564, 1053860, 1054512, 1065507, 1069998, 1069999, 1071165 , 1071167, 1088473, 1088475, 1104109, 1104110, 1121837, 1128074, 1128623, 1150839, 1153465, 1161360, 1165775, 1168905, 1168906, 1171488, 1173628, 1175898, 1177389, 1177390, 1181586, 1181587, 1184511, 1185509, 1185511.   Model Number PPC655, Lot Numbers: 1032473, 1057790, 1086562, 1088470, 1166995, 1176293.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
  • Product Description
    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 || BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
  • 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

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: PPC484, PPC654, PPC655, Affected: PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, PAK6455
  • Manufacturer
  • Model / Serial
    Item: PPC484, PPC485, PPC654 and PPC655.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
  • Product Description
    Provide Protection Cap || Dental implants
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Dental products - dental implants
  • Manufacturer
  • Model / Serial
  • Product Description
    Biomet 3i: provide protection caps
  • Manufacturer
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