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OTC denture cushion, repair kit downclassification to Class I recommended by FDA panel.

This article was originally published in The Tan Sheet

Executive Summary

OTC DENTURE CUSHION/PAD, REPAIR KIT DOWNCLASSIFICATION TO CLASS I from Class III is appropriate with "restrictions" placed on the reclassification to address safety concerns, FDA's Dental Products Advisory Panel recommended in a 6-5 vote at a Feb. 12 meeting in Gaithersburg, Md. Panel members generally agreed that the devices pose no major health risks; debate focused on whether the devices should be placed in Class I, the least restrictive regulatory class, or Class II.
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