Dharma Cavity Varnish with Fluoride — Class II medical device recall Z-0475-2015
Terminated recall by Dharma Research, Inc., reported 2014-12-03, distributed in CA, FL, IL, PA, PR. During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
| Recall number | Z-0475-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dharma Research, Inc., Miami, FL, United States |
| Recall initiated | 2014-09-29 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-10-03 |
| Distributed | CA, FL, IL, PA, PR |
| Countries outside the US | AE, CO, DO, GT, HN, NI, PK, SA, TR, TT |
| Quantity | 2,842 |
| Reason classes | unapproved product |
| Model numbers | 14-00015 |
Product
Dharma Cavity Varnish with Fluoride
Reason for recall
During an FDA inspection, it was found that the products are being marketed without a cleared 510k.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0475-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.