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Emery Enterprise, Inc dba ITL Dental, EU FSCA 1-30-2024, ITL Dental Dental Implant System

Emery Enterprise, Inc dba ITL Dental, EU FSCA 1-30-2024, ITL Dental Dental Implant System

During a MDSAP/EU MDR 2017/745 audit a template with the CE mark was put on 7 devices to be shipped - it was discovered, and the labels changed. Even though ITL Dental does not ship directly to the EU, the auditor thought that there still could be a

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