SDI Gains Federal Marketing Clearance for a Unique Silver Diamine Fluoride Formula

SDI North America has received registration approval from the federal Food and Drug Administration to market Riva Star in the United States as a “new generation” silver diamine fluoride (SDF) desensitizer. This is only the second SDF product to be approved for use by U.S. clinicians. Widely used off-label for caries management, SDF is gaining acceptance among U.S. providers — and though relatively new to American dentists, the material has been used for this indication in other parts of the world for decades. For example, the company reports registering Riva Star in key Latin American countries, including Brazil, as an anti-caries agent.

In addition to SDF, Riva Star’s key ingredient is potassium iodide, and the proprietary formula is said to minimize the risk of staining caries lesions black, resulting in an esthetically acceptable tooth-colored appearance for the patient. The twostep, color-coded system is said to be easy to use, and the product’s capsule packaging helps prevent spills and staining of operatory surfaces.

From Decisions in Dentistry. May 2018;4(5):10.

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