A-A-54447
Syringe tips. The syringe insert tips shall be made of polypropylene and shall fit the applicator for the purpose intended. The tips shall be 3/4 inch ± 1/16 inch in length and shall have an inside diameter of 1/16 inch ± 1/64 inch.
Mixing wells. The mixing well trays shall each have 10 mixing wells, shall be made of polypropylene and shall be suitable for the purpose intended. The trays shall be 4 1/4 inches ± 1/4 inch in length and 2 inches ± 1/4 inch in width.
Mixing sticks. The mixing sticks shall be made of acetal copolymer and shall be suitable for the purpose intended. The sticks shall be 4 3/4 inches ± 1/4 inch in length.
Instructions for use. Instructions for use shall be clear and complete and shall describe the mixing of the universal and catalyst resins, operation of the applicator, and the use of the etchant. Mixing the two resins together shall initiate the polymerization reaction. The mixed sealant shall have a working time of 60 to 100 seconds and a maximum setting time of 2.25 minutes when tested as specified below. The sealant shall be easily and conveniently applied by means of a syringe type applicator featuring disposable syringe insert tips.
The sealant shall seal pits, grooves, and fissures in conjunction with the acid etch technique so as to resist dental caries. The sealant shall be retained by the pits and fissures for a minimum of 4 years. The sealant shall be an unfilled resin system which will wear away in a maximum of 48 hours if inadvertently applied to the areas of direct occlusal contact. The sealant kit shall be recognized as acceptable or certified by the Council on Dental Materials, Instruments and Equipment of the American Dental Association.
Certification. The manufacturer shall furnish a statement to the procuring activity, prior to award of contract or purchase order, that the sealant has been tested clinically and found effective in sealing pits, grooves and fissures in teeth to resist dental caries, and that the sealant is free from toxicity as required by this specification. Supporting data shall be forwarded with the statement or made available request of the procuring activity. If the data furnished is found inadequate, additional information shall be furnished on request. The Government reserves the right to examine the data, to consult with the testing activity, and to determine whether such data is satisfactory and acceptable.
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