A-A-54398
Description. The cavity lining and thinner set shall be suitable for use in dental operative procedures. The following components shall be present in each unit of issue of the liner and solvent set.
One bottle containing a minimum of 20 ml of cavity lining.
One bottle containing a minimum of 20 ml of thinner.
One set of instructions for dilution with thinner and for use of cavity lining.
Working properties. The cavity lining shall spread readily over the entire surface of the cavity. It shall adhere to the surfaces and quickly dry to a thin, semipermeable film within 10 seconds of application. It shall not inhibit or alter the polymerization of polymeric restorative material and shall be compatible with dental cavity base materials. The lining shall be capable of sealing the freshly cut dentin surfaces from acid penetration, corrosion products, and leachates so as to protect the dental pulp from toxicity. The lining shall maintain the morphology of the prepared dentin surfaces and be hydrophobic when dry. The lining shall protect exposed surfaces of dentin in teeth that have been prepared for restorations.
Spread. The cavity lining shall have a spread diameter of 13 to 18 millimeters when tested as specified herein.
Percent solids. The cavity lining shall have a percent solids of 7.9 to 8.2% when tested as specified herein.
Viscosity. The cavity lining shall have a viscosity of 3 to 6 centipoises when tested as specified herein.
Instructions. Detailed and accurate instructions for use of lining and thinner shall be furnished.
Certification. A statement shall be forwarded to the procuring activity, prior to award of contract or purchase order, that the lining has been tested clinically and found effective in lining a cavity as described above, and that the lining is free from toxicity and irritation. Supporting data shall be forwarded with the statement or made available on 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 test activity and to determine whether such data is satisfactory and acceptable.
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