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U.S. Department of Health and Human Services

Class 2 Device Recall Dharma Cavity Varnish with Fluoride

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  Class 2 Device Recall Dharma Cavity Varnish with Fluoride see related information
Date Initiated by Firm September 29, 2014
Date Posted December 01, 2014
Recall Status1 Terminated 3 on October 03, 2016
Recall Number Z-0475-2015
Recall Event ID 69386
Product Classification Varnish, cavity - Product Code LBH
Product Dharma Cavity Varnish with Fluoride
Code Information All Lots - Item #14-00015
Recalling Firm/
Manufacturer		 Dharma Research, Inc.
5220 Nw 72nd Ave
Bay 15
Miami FL 33166-4860
For Additional Information Contact Ricardo A. Carles
305-482-9669
Manufacturer Reason
for Recall		 During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
FDA Determined
Cause 2		 No Marketing Application
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.
Quantity in Commerce 2,842
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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