Recall Z-0475-2015— Dharma Research, Inc.

Name: FDA recall Z-0475-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-29

Class II · Terminated

Class II FDA medical device recall by Dharma Research, Inc., initiated 2014-09-29, terminated 2016-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Dharma Cavity Varnish with Fluoride. Reason: During an FDA inspection, it was found that the products are being marketed without a cleared 510k..

Recalling firm: Dharma Research, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Terminated: 2016-10-03
Firm location: Miami, FL, United States

Product description

Dharma Cavity Varnish with Fluoride

Reason for recall

During an FDA inspection, it was found that the products are being marketed without a cleared 510k.

Data sourced from openFDA. This site is unofficial and independent of the FDA.