Fluoride toothpaste is classified as an OTC drug by FDA because fluoride is an active drug ingredient with an approved therapeutic claim (cavity prevention). This means it must comply with FDA's OTC monograph for anticaries drug products, including specific labeling and formulation requirements, in addition to its HTS classification under 330610 as a dentifrice.

Standard dental floss yarn under 330620 is generally treated as a consumer product rather than a medical device, and it does not typically require FDA device clearance. However, floss products that incorporate drug coatings or make therapeutic claims beyond basic cleaning may attract additional regulatory scrutiny. Classification as a device depends on the product's intended use and labeling.