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ENDOSSEOUS DENTAL IMPLANT 510(k) GUIDANCE TO SERVE AS CLASS II SPECIAL CONTROL; DOWNCLASSIFICATION PLANNED FOR UNCOATED SCREW-TYPE IMPLANTS

This article was originally published in The Gray Sheet

Executive Summary

A revised 510(k) guidance document for uncoated screw-type endosseous dental implants will serve as a special control for the devices when they are downclassified to Class II, FDA staffers say.
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