FDA 483 - Sirona Dental Systems GmbH - January 19, 2022

This document is a 510(k) summary (K210259) submitted by Parkell, Inc. for their Self-Adhesive Cement, a dental device. The submission details the device's description as a two-component, dual-cured, self-etching, self-adhesive resin cement intended for luting indirect restorations. It also identifies the primary predicate device as Dentsply International's Self-adhesive Cement (K073173).