This International Standard specifies requirements and their test methods for total digestible fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This International Standard covers fluoride varnishes to be applied by dental health care workers.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because it: Conflicts with an existing regulation. Intended use of caries prevention conflicts with intended use of the device in 21 CFR 872.3260; see Procode listing below. Therefore the excepted clauses do not satisfy a premarket requirement under the FD&C Act for caries prevention.