Dental Devices; Classification of Sulfide Detection Device

The Food and Drug Administration (FDA) is classifying the sulfide detection device into class II (special controls). The special controls that will apply to the sulfide detection device are restriction to prescription use, conformance with recognized standards relating to biocompatibility, electrical safety and sterility, submission of performance data from analytical and clinical studies demonstrating device effectiveness and adherence to specific labeling requirements. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Modernization Act of 1997. The agency is classifying sulfide detection devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.