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CariFree Fluoride Varnish
Dental Alliance Holdings LLC · Model CTx2 · UDI-DI 00856596006366
LBH
Prescription
10
510(k) clearances
217
Adverse events
9
Recalls
93
Facilities
Description
A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-21 | Keystone Industries | A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526). |
| 2023-05-23 | Young Dental Manufacturing I, LLC | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. |
| 2019-10-30 | Young Dental Manufacturing Co, LLC | Product shelf life may be shorter than that indicated on the label. |
| 2018-07-12 | Ultradent Products, Inc. | Dental varnish has the possibility of having an unpleasant and off flavor. |
| 2018-07-06 | 3M Company - Health Care Business | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
| 2014-10-24 | Discus Dental LLC | Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual barrel syringe instead |
| 2014-09-29 | Dharma Research, Inc. | During an FDA inspection, it was found that the products are being marketed without a cleared 510k. |
| 2014-09-29 | Dharma Research, Inc. | During an FDA inspection it was found that the products are marketed without a cleared 510k. |
| 2014-04-23 | Heraeus Kulzer, LLC. | The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.