IPS INLINE POM SYSTEM

About This 510(k) Submission

K071848 is an FDA 510(k) clearance for the IPS INLINE POM SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on August 30, 2007, 56 days after receiving the submission on July 5, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.