Class II — Dharma Research, Inc.
| Recalling firm | Dharma Research, Inc. |
|---|---|
| Registered facility | Dharma Research/Medeco International (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During an FDA inspection, it was found that the products are being marketed without a cleared 510k. |
| Product | Dharma Cavity Varnish with Fluoride |
| 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. |
| Initiated | 2014-09-29 |
| Classified | 2014-11-26 |
| Terminated | 2016-10-03 |
| Recall number | Z-0475-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dharma Research, Inc. (Z-0475-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69386/
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