Device Recall Sealapex Xpress

  • Modelo / Serial
    lot # 5-1310
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
  • Descripción del producto
    Sealapex Xpress, Part No. 33639 || The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA