Premarket Notification 510(k) is not required before marketing most Class I as well as some Class II dental medical devices in the United States. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.usfda.info/510k-exempt-dental-medical-devices/
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