Device product
Dharma Cavity Varnish with Fluoride
Z-0475-2015
Product summary
- Event
- Event 69386
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,842
- Official record key
device-enforcement:Z-0475-2015
Official wording
Reason: During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
Code information: All Lots - Item #14-00015
Distribution pattern: 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.
Derived failure modes
-
Unknown
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.