A-A-51727
Performance certification. The offeror shall furnish a statement to the procuring activity, prior to award of contract or purchase order, that the sealing compound has been clinically tested and found effective in providing a chewing surface in sealing access openings to root canals and is free of toxicity as required. Supporting data shall be forwarded with the statement or made available on request by 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.
Instruction. Adequate and accurate instructions for use shall be included with each package. Instructions shall include the information that the patient can chew on filling 1 hour after treatment.
Workmanship. Sealing compound shall show no separation, shall be free of chemical or color changes, hardening in the tube, or any other defect which detract from its appearance or may impair its serviceability.
Unit. Package(PG). One package containing four tubes, each tube containing a minimum of 7 grams of sealing compound and a key which is used to facilitate dispensing of sealing compound, constitutes one unit.
Quality Assurance Provisions.
Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contact or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.
Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.
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