Events

Safety Alert for LASER LIGTH - DENTAL EQUIPMENT

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA.

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 ID
    752
  • Date
    2003-10-30
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    considering paragraph 3 of art. 111 of the Internal Regulation approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the arts. 12 and 25 and 50 of Law no. 6,360, of September 23, 1976, c / c, arts. 14, 35 and 75 of Decree No. 79.094 of January 5, 1977, c / c RDC-185, of October 22, 2001; considering items I, IV, V, X and XXIX of art. 10, of Law no. No. 6,437, August 20, 1977; considering the decision rendered to fls. 40 in the case file 25351.014843 / 2003-95
  • Reason
    Do not have registration with anvisa, imposing health risk.
  • Action
    Determine, as a measure of health interest, throughout Brazil, the prohibition of advertising and publicity, exposure to the sale and sale of the product LASER LIGTH, of KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA, located at Rua Gastão Vieira nº 471, Jardim Santa Felicia, São Carlos / SP, for not having registered with ANVISA, imposing health risk.

Device

LASER LIGTH - DENTAL EQUIPMENT

Manufacturer

KONDORTECH EQUIPAMENTOS ODONTOLÓGICOS LTDA
  • Source
    ANVSANVISA