FDA panel confirms down-classification of dental implants
GAITHERSBURG, Md., USA: The Food and Drug Administration has announced that it has moved closer to reclassifying blade-form endosseous dental implants from Class III, which are subject to premarket approval, to Class II devices. In mid-July, a specialist panel recommended the reclassification from high-risk to medium-risk medical devices.
As reported by Dental Tribune ONLINE earlier this year, an order recommending reclassification to Class II was issued in January. As the FDA had received responses from one clinician and one manufacturer of endosseous dental implants that also recommended reclassification to Class II, the FDA Medical Devices Advisory Committee's Dental Product Panel met on July 18, in order to discuss the available scientific evidence regarding the use of such implants. The order served as the basis for scientific discussion by the panel members.
After having reviewed ten studies, the panelists concluded that available evidence suggests that blade-form endosseous dental implants, which are usually placed into the maxilla or mandible to support a dental restoration, are effective and have a satisfactory long-term safety profile. The majority of studies reported a success rate of 90 to 100 percent after five years of follow-up. Only one study reported a success rate of 84.2 percent and this was in males only. In addition, long-term device survivability of 100 percent was widely reported.
Overall, the panelists found that general controls alone are not sufficient owing to identified health risks. However, they said that they should be combined with a number of special controls to secure a satisfactory safety and effectiveness level.
Among other measures, the panelists recommended mechanical performance tests under simulated physiological conditions to demonstrate maximum load and corrosion testing under simulated physiological conditions to demonstrate the corrosion potential of each metal or alloy. Moreover, the devices must be demonstrated to be biocompatible, safe and effective by documented clinical experience.