FDA 483 - Parkell, Inc. - January 29, 2020

This document is a Premarket Notification (Traditional 510(k)) submitted by Parkell, Inc. for their Self-Adhesive Cement, a Class II medical device. The submission, dated January 21, 2021, seeks clearance for a dual-component, dual-cured high-strength cement intended for various indirect dental restoratives. This is a regulatory submission and does not contain any inspectional observations or violations.