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Enamelite, LLC
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NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN is an FDA 510(k)-cleared medical device (K030859) manufactured by Enamelite, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 2003. Regulation: 8.