FDA proposes device reclassification
Federal agency inviting comments through April 15
The U.S. Food and Drug Administration invites comments through April 15 on proposed reclassification for regulatory purposes of blade-form endosseous dental implants with general and special controls to provide reasonable assurance of their safety and effectiveness.
The Jan. 14 Federal Register notice invites electronic comments on Docket No. FDA-2012-N-0677 to www.regulations.gov and written submissions by mail/hand delivery/courier to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
The proposed order describes the blade-form endosseous dental implant as a device placed into the maxilla or mandible and composed of biocompatible material, such as titanium alloy or commercially pure titanium, with sufficient strength to support a dental restoration, such as a crown, bridge or denture, intended for the purpose of replacing tooth (or teeth) roots and extending a support post through the gingival tissue into the oral cavity to restore chewing function.
"FDA has been reviewing these devices for many years and their risks are well known," the notice said.
"A review of the applicable clinical literature indicates that the device has a high success rate (remaining implanted/not removed) and that few relevant adverse events have been reported in the case of these devices or related devices suggesting that the device has a high long-term safety profile."