Initial LiSi Press

About This 510(k) Submission

K153136 is an FDA 510(k) clearance for the Initial LiSi Press, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on June 30, 2016, 244 days after receiving the submission on October 30, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.