SAFETY AND EFFICACY DATA
Specification No. 39 established the following requirements:
– that the working time for type I sealants is not less than 45 seconds;
– that the setting time is within 30 seconds of the manufacturer’s instructions and does not exceed three minutes;
– that the curing time for type II sealants is not more than 60 seconds;
– that the depth of cure for type II sealants is not less than 0.75 millimeters;
– that the uncured film thickness is not more than 0.1 mm;
– that sealants meet the biocompatibility requirements of American National Standard/American Dental Association Document No. 41 for Recommended Standard Practices for Biological Evaluation of Dental Materials.4
