Recall of Dharma Cavity Varnish with Fluoride

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dharma Research, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69386
  • Event Risk Class
    Class 2
  • Event Number
    Z-0475-2015
  • Event Date Posted
    2014-12-01
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2016-10-03
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Varnish, cavity - Product Code LBH
  • Reason
    During an fda inspection, it was found that the products are being marketed without a cleared 510k.
  • Action
    On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669.

Device

  • Model / Serial
    All Lots - Item #14-00015
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.
  • Product Description
    Dharma Cavity Varnish with Fluoride
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Dharma Research, Inc., 5220 Nw 72nd Ave, Bay 15, Miami FL 33166-4860
  • Manufacturer Parent Company (2017)
  • Source
    USFDA