Zdrowie i gospodarka · 12/05/2004

FDA Reclassifies Root-Form Endosseous Dental Implants and Abutments from Class III to Class II

The US Food and Drug Administration (FDA) is reclassifying root-form endosseous dental implants and endosseous dental implant abutments from a Class III to a Class II device, requiring special controls, due to new information. This reclassification is based on the FDA's own initiative and is part of a broader regulatory framework that includes the Federal Food, Drug, and Cosmetic Act and the Medical Device Amendments of 1976.