U.S. Food and Drug Administration

The Road to a Revolutionary Smile: Navigating the Regulatory Maze of Enamel Regeneration

For decades, the concept of regenerating tooth enamel has been the "holy grail" of dentistry. Recent breakthroughs in stem cell biology and biomimetic materials have brought this future tantalizingly close. We now see lab-based successes in creating ameloblast-like cells that can secrete new enamel.

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