FDA regulation of dental devices: past, present, and future.
The organization of the Food and Drug Administration as related to dental devices is described. The classification according to safety and efficacy of devices is described and examples are given. The process of submitting a Premarket Notification [(510(k)] for class I and II devices, a Premarket Approval (PMA) for class III devices and an Investigational Device Exemption (IDE) are described. The clinician is told how to report problems with medical devices.
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Food and Drug Administration, Dental Devices Branch, Rockville, MD 20850.
D003748:Dental Equipment; D003762:Dental Instruments; D004869:Equipment Safety; D007879:Legislation, Dental; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000639:trends