WASHINGTON, June 1 -- Food and Drug Administration has issued a rule called: Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device.
The rule was published in the Federal Register on June 1 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is classifying the intraoral cooling device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the intraoral cooling device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety ...