Dental implant reclassification
This article was originally published in The Gray Sheet
Executive Summary
Root-form endosseous dental implants and abutments downclassified to Class II with special controls under an FDA final rule and guidance May 12. The implants support prosthetic devices such as artificial teeth. Reviewing comments responding to a May 2002 downclassification draft guidance, FDA notes that sterility issues are adequately addressed by QSR requirements; one commenter opposing the downclassification had suggested the implants potentially could be contaminated at placement...