Conical Abutment Cylinder

  • Model / Serial
    Model SWCA62, Lot 848478
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.
  • Product Description
    "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". || Attach an implant to an implant restoration.
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    (1) Conical 25º Angled Abutment 4, 1mm(D) X 4mm (H) M/N: AC4425, L/N: 887628-5; (2) Conical Abutment Gold Standard ZR 6mm (D) X 2mm(H) M/N: SWCA62, L/N: 848478
  • Product Description
    Dental implants supra structure device, permanent
  • Manufacturer