FDA Medical Device Recalls (openFDA)
Dharma Research, Inc.: Dharma Cavity Varnish with Fluoride
- Recall number
- Z-0475-2015
- Recalling firm
- Dharma Research, Inc.
- Product
- Dharma Cavity Varnish with Fluoride
- Status
- Terminated
- Initiated
- 2014-09-29
- Posted
- 2014-12-01
- Terminated
- 2016-10-03
- Reason
- During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
- 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
- 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.
- Lot, serial or model codes
- All Lots - Item #14-00015
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LBH
- Firm FEI
- 3010131268
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28