Dental Devices; Effective Date of Requirement for Premarket Approval of Endodontic Dry Heat Sterilizer

摘要

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the endodontic dry heat sterilizer, a medical device. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements, and the benefits to the public from use of the device. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of the device based on new information.