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Ivoclar Vivadent, AG
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SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO is an FDA 510(k)-cleared medical device (K123304) manufactured by Ivoclar Vivadent, AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2013. Regulation: 8.
