The ADA became involved in the development of US national standards for dentistry in the 1920’s. These initial standards characterized dental products that were currently being used successfully in the dental marketplace. For instance, one of the early ADA standards was entitled “Dental Casting Gold Alloy” and included composition and physical property requirements for these materials based on existing products. Another similar ADA standard describes the requirements for “Dental Base Metal Casting Alloys.” These are both examples of material based standards. However, predicated on the goal of performance based standards, these standards and possibly others could be combined to form one standard on removable dental prostheses. This standard would describe the performance requirements of a safe and efficacious material for this particular dental application. It would also be a goal that the methods used to test these requirements be “clinically relevant.”     

 The purpose of this paper is to discuss the movement of dental standards towards performance based requirements using clinically relevant test methods, and the consequences and challenges this poses to standard developers, dental manufacturers, and regulators.