Interactions as seen by an industry representative among the FDA, the ADA, and industry in preparing a restorative material for market.
The regulation of a restorative material in the international and the American markets is discussed. The 510(k) process of approval by the Food and Drug Administration allows marketing of safe, effective, and improved materials in the shortest time at the lowest cost. The American Dental Association contributes to developing consensus performance standards in the United States. Acceptance of International Standards Organization standards is discussed.
Dougherty
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Dentsply International, York, PA 17404.
D000571:American Dental Association; D003764:Dental Materials / Q000592:standards*; D003793:Dental Restoration, Permanent / Q000592:standards; D017277:Drug Approval; D004345:Drug Industry; D005060:Europe; D014481:United States; D014486:United States Food and Drug Administration
D003764:Dental Materials