CERCON CERAM EXPRESS CERAMIC SYSTEM

About This 510(k) Submission

K041707 is an FDA 510(k) clearance for the CERCON CERAM EXPRESS CERAMIC SYSTEM, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on July 30, 2004, 37 days after receiving the submission on June 23, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.