Device Recall Breeze SelfAdhesive Resin Cement

  • Model / Serial
    Lot # 200466
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide (USA) and the countries of Vietnam, Jordan,Turkey, and Italy.
  • Product Description
    Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for cementation of porcelain, resin, and metal-based inlays, onlays, crowns, bridges, and posts.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
  • Product Description
    Breeze Self-Adhesive Resin Cement, Part Number: N97A, || Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
  • Manufacturer