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Zdrowie i gospodarka · 14/05/2002

Dental Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments

The Food and Drug Administration (FDA) is proposing to reclassify from class III to class II root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. FDA is also proposing to reclassify endosseous dental implant abutments, which are separate components that are attached to the implant and intended to aid in prosthetic rehabilitation from class III to class II. This reclassification is being proposed on the Secretary of Health and Human Services (the Secretary's) own initiative based on new information. The agency is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document that would serve as the special control if this proposal becomes final.

Source: Federal Register — Food and Drug AdministrationOpen original release →