FDA Ends Device Approval Requirement for Dental Implant Devices

The Food and Drug Administration announced the reclassification of blade-form endosseous dental implants as Class II medical devices subject to special controls. The dental implants were previously classified in Class III and required premarket approval. The reclassification will take effect July 18; Although the devices will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling..