Piezon Built-in Kit, Piezon Built-in Kit LED

About This 510(k) Submission

K191079 is an FDA 510(k) clearance for the Piezon Built-in Kit, Piezon Built-in Kit LED, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on August 16, 2019, 115 days after receiving the submission on April 23, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.