Device Recall SybronEndo Elements Obturation Unit;

  • Modèle / numéro de série
    Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy || The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Société-mère du fabricant (2017)
  • Source
    USFDA