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Dental devices

This article was originally published in The Gray Sheet

Executive Summary

FDA downclassifies endosseous dental implant accessories from Class III to Class I, as "these devices do not have a history of risks associated with them." The "drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments," along with other manually powered accessories, are exempt from premarket notification, the agency explains in an Oct. 10 Federal Register notice
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