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OTC denture cushion downclassifications sought by Mentholatum and Brimms.

This article was originally published in The Gray Sheet

Executive Summary

SOFT PLASTIC DENTURE CUSHION DOWNCLASSIFICATION: FDA SAFETY CONCERNS "are not applicable if cushions are only used temporarily until a dentist can be seen," Mentholatum argues in a July 26 petition requesting that FDA reclassify the over-the-counter devices from Class III to Class I. The petition was submitted in response to FDA's July 11 proposed call for premarket approval applications for OTC denture cushions or pads and repair kits ("The Gray Sheet" July 17, p. 15). The proposed rule covers all denture cushions/pads except those made of wax-impregnated cotton cloth and intended for one-day use, which are in Class I.

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