07/12/2022 Other Services
Premarket Notification 510(k) is not required before marketing 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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