Dharma Research, Inc.
Medical device manufacturer in Miami, FL.
1510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K150696 | Jade 37% Phosphoric Acid Etchant GelKLE · Traditional | 06/23/2015SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0476-2015 Class II | Dharma Cavity Varnish 15mLDuring an FDA inspection it was found that the products are marketed without a cleared 510k. | 09/29/2014Terminated |
| Z-0475-2015 Class II | Dharma Cavity Varnish with FluorideDuring an FDA inspection, it was found that the products are being marketed without a cleared 510k. | 09/29/2014Terminated |