FDA has received several Requests for Designation (RFD) for dental prophylaxis pastes incorporating a drug component. Prophylaxis pastes are indicated for cleaning and polishing teeth as part of a professionally administered prophylaxis treatment. Prophylaxis pastes that do not contain a drug component are devices, as described in the classification regulation for "oral cavity abrasive polishing agents" in 21 CFR 872.6030. Dental prophylaxis pastes with a drug component combine drug and device components, and are therefore combination products within the meaning of section 503(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 353(g)) (Act). Accordingly, review responsibility for these products is assigned based on the Agency's determination of the product's "primary mode of action" (21 CFR § 3.4).
For the specific RFD's submitted, FDA has determined that the prophylaxis paste component functions as an abrasive agent intended to clean and polish the teeth, while the drug component has played a secondary role, augmenting the safety and/or effectiveness of the prophylaxis paste. In these cases, the combination products acted primarily by cleaning and polishing teeth. FDA has concluded in these cases that the primary mode of action for the combination product is that of the device component, and has assigned the Center for Devices and Radiological Health (CDRH) primary responsibility for premarket review and regulation under the medical device provisions of the Act. CDRH has conducted its reviews in consultation with the Center for Drug Evaluation and Research (CDER). The assignment of primary review responsibility to CDRH in these cases is consistent with Sections VII.A.2 and VIII.A.5 of the current Intercenter Agreement between CDER and CDRH, which assigns CDRH review responsibility for combination products in which the device component fulfills the product's primary intended purpose.
Such products have not met the 510(k) exemption requirements of 21 CFR 872.9. Sponsors wishing to discuss regulation of a particular prophylaxis paste with drug component should contact the Dental Devices Branch in the Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID), Office of Device Evaluation, CDRH by telephone at (301) 796-5580.