Sirona Dental Systems GmbHJanuary 19, 2022

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

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Record Details

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).

Company: Sirona Dental Systems GmbH
Inspection Date: January 19, 2022
Product Type: Device
Office: FDA District Office — Edgewood, New York
Person: La-Shaunda Joseph

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ID · ce55ac4e-d65e-4524-b47f-9cfff7c7ad20