Events

Safety Alert for Endodontic Needles (Dental Root Canal Needles) K-FILE DENSPLY

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Manufacturer: Dentsply Maillefer, Switzerland Sender: Zhengzhou Smile Dental Equipment Co., Ltd., China.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    13
  • Date
    2016-03-07
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lithuania.
  • Extra notes in the data
  • Reason
    Endodontic needles (dental root canal needles) k-file densply bears the ce conformity marking, but no notified body number is given (does not meet the requirements of mn 4: 2009 item 40).
  • Action
    Disallowed to market

Device

Endodontic Needles (Dental Root Canal Needles) K-FILE DENSPLY

Manufacturer

Manufacturer: Dentsply Maillefer, Switzerland Sender: Zhengzhou Smile Dental Equipment Co., Ltd.,...
  • Manufacturers representative
    Signata UAB
  • Source
    MH