Z-0475-2015Class II

Dharma Cavity Varnish with Fluoride

Name: Z-0475-2015 Dharma Cavity Varnish with Fluoride
Creator: Dharma Research, Inc.
Published: 2014-09-29
License: https://open.fda.gov/license/

Dharma Research/Medeco International / initiated 2014-09-29 / Terminated

FDA source

Dharma Research, Inc. began a recall of Dharma Cavity Varnish with Fluoride on 2014-09-29. FDA classified it as Class II and gives the reason as "During an FDA inspection, it was found that the products are being marketed without a cleared 510k". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0475-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-29
Posted: 2014-12-01
Terminated: 2016-10-03
Recalling firm: Dharma Research/Medeco International
Product: Dharma Cavity Varnish with Fluoride
Product code: LBH Varnish, Cavity
Reason for recall: During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
FDA root cause: 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.
Product codes and lots: All Lots - Item #14-00015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0475-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26
Z-0476-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code LBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)