ENDOSSEOUS BLADE IMPLANTS SHOULD REMAIN IN CLASS III, FDA PANEL SAYS; AGENCY OPEN TO FUTURE DOWNCLASSIFICATION; ROOT FORM IMPLANTS, ABUTMENTS TO CLASS II
This article was originally published in The Gray Sheet
Executive Summary
FDA is open to receiving additional data to support the downclassification of blade-type endosseous implants and is not planning to call for premarket approval applications for the devices in the near future, agency staffers say. Blade implants are the only type of endosseous devices that FDA should keep in Class III, FDA's Dental Products Advisory Panel recommended at a Jan. 13 meeting in Rockville, Maryland.