OTC denture cushion classification as low-risk devices sought by Mentholatum.
This article was originally published in The Tan Sheet
Executive Summary
OTC DENTURE CUSHION SAFETY CONCERNS "NOT APPLICABLE" if the products are used as a temporary fix until a dentist can be seen, Mentholatum argued in a July 26 petition requesting that FDA reclassify the over-the-counter devices from Class III (high risk) to Class I (lowest risk). The petition was submitted in response to FDA's July 11 proposal calling for premarket approval applications for OTC denture cushions or pads and repair kits ("The Tan Sheet" July 17, p. 20).