Fluoride Varnishes

ANSI/ADA Standard No. 117 Executive Summary

What is ANSI/ADA Standard No. 117 about?

Fluoride varnishes are used in dentistry primarily for caries prevention and reduction of dentine hypersensitivity and are applied directly on the outer surfaces of teeth and fillings. This standard provides the requirements and test methods for determining total digestible fluoride content in dental varnishes containing fluoride and what information the manufacturer should provide on the product labeling. It covers fluoride varnishes to be applied by dental health care workers.

What are the requirements I should know about for fluoride varnishes?

The average total fluoride content shall not deviate by more than 20% from the stated amount on the package.

What’s the bottom line?

ANSI/ADA Standard No. 117 requires that the type of fluoride and the total fluoride content of the fluoride varnish shall be stated on the package label. It provides the laboratory test method for total fluoride content to determine if the product meets the requirement for the amount stated on the package.