The Food and Drug Administration (FDA) is a section of the Department of Health and Human Services of the United States Government, and its primary responsibility is to control the distribution of food, drugs, and medical devices within the country while ensuring public safety. The sale and distribution of dental implants is under the regulatory control of the FDA. Device classification, procedures for approval, and the current status of the approval process for endosseous implants are described in this article. The premarket approval procedure of the FDA is compared with the American Dental Association certification process. Issues related to the safety and effectiveness of dental implants are discussed.