FDA Device

Dharma Cavity Varnish with Fluoride

Hazard

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

What You Should Do

Remedy

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.

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Products

Dharma Cavity Varnish with Fluoride
Brand
Dharma Research, Inc.
UPC
All Lots - Item #14-00015

Units Affected

2,842

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