In Brief: Endodontic dry heat sterilizers
This article was originally published in The Gray Sheet
Executive Summary
Endodontic dry heat sterilizers: FDA calls for premarket approval applications or product development protocols (PDP) for the dental sterilization systems in a final rule published in the Jan. 21 Federal Register. PMAs or PDPs are due by April 21. The rule follows a June 1995 recommendation of FDA's Dental Devices Panel that the devices remain in Class III because they may not always sterilize dental instruments adequately...