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The test results indicate the Prismatik BruxZir Shaded Blank is comparable to the predicate device. 6660 21 CER Common Name Porcelain powder for clinical use Classification Class 11 Panel Dental IDENTIFICATION OF PREDICATE DEVICE Prismatik Tm Clinical Zirconia Prismatik Tm CZ -K060 104 SIDENTAICRAFT D. Fda.gov/MedicalDevices/ResourcesforYou/lndustry/defaulthtm. Also please note the regulation entitled Misbranding by reference to premarket notification 2ICFR Part 807. BruxZir Shaded has been...
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