RotoMetrics Rotorepel Rx passes FDA review

The formulation for RotoMetric’s RotoRepel Rx nonstick rotary die treatment has undergone a US Food and Drug Administration regulatory compliance review, migration testing, and toxicological safety assessment.

Rotometrics Rotorepel Rx passes FDA review

RotoRepel Rx is safe for intended use in conversion of parts, devices and labels. Additionally, RotoRepel Rx is compliant with US FDA food contact regulations. RotoRepel Rx is filed with the US Food and Drug Administration under Master File for Devices (MAF) #2975.

‘We are extremely excited for new RotoRepel Rx to be on file with the US FDA,’ said Keith Laakko, vice president of marketing for RotoMetrics. ‘RotoRepel Rx opens the door for customers to use our innovative no-stick and enhanced die performance treatment in new applications. Customers have access to our filing as a portion of a 510(k) submission to the FDA. This is great news for customers converting parts, devices and labels in medical and other related industries. Additionally, our formulation is compliant with food contact regulations so it safe for intended use in food contact applications for packaging, parts, and labeling.’