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Warning Letter Roundup & Recap – January 19, 2016

This article was originally published in The Gray Sheet

Executive Summary

DiamoDent didn't get a new 510(k) or PMA after modifying its Cement-On Post, which resulted in a major change in the device's intended use; FDA says information on Eclipse Aesthetics' website was false and misleading. Two device warning letters were listed by FDA this week.

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