FDAFDA · Food and drugs·Recall number Z-0475-2015
Dharma Cavity Varnish with Fluoride
Published December 3, 2014 · Recall initiated: September 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dharma Research, Inc.
- Distributor
- 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.
- Lot
- All Lots - Item #14-00015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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