A-A-54441
Adhesion. A human tooth and a stainless steel orthodontic lingual button shall be used. The tooth shall be prepared in accordance with standard dental procedures prior to applying the cement. The button shall be attached to the tooth and kept moist and stored at 37.0° ± 0.5°C for three hours. The tooth and button shall then be separated.
The adhesion test is not required on all lots provided the following conditions are met. The first lot or batch passes the adhesion test. The contractor provides certification that the lots or batches being offered to the government are of the same formulation and manufacturing process as the first lot.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.
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