Events

Safety Alert for DYCAL ADVANCED FORMULA II, Registration - 10186370113, Lot 886754F

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dentsply Indústria e Comércio 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
    1597
  • Date
    2015-04-14
  • 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
    The company informs that the hardening of the base paste of the product in question does not pose a risk to the population, since it does not give the product new characteristics that are harmful to health, but prevents its use.
  • Reason
    The product presented a change in the consistency in the base paste of lot 88674f, which consists of hardening of the product, preventing dispensing, making it difficult to use the product.
  • Action
    The company advises customers who have purchased the product to preventively store it and get in touch with Dentsply for the replacement.

Device

DYCAL ADVANCED FORMULA II, Registration - 10186370113, Lot 886754F

Manufacturer

Dentsply Indústria e Comércio Ltda.