1. Dr Mumtaz ul Islam Scholar M Phil 1st year Science of Dental Materials Ghandhara University Peshawar Pakistan E Mail drmumtazulislam@gmail.com Cell 923339360524

2. The existence of materials evaluation standards does not preclude any one from manufacturing marketing buying or using dental or medical devices that do not meet these standards specifications and standards have been developed to aid 3. Producers users and consumers in the evaluation of the safety and effectiveness of dental products The decision of producers to test their materials according to national and international standards is purely voluntary 4. Producers / marketers of products and devices are expected to meet the safety standards established for those products in the countries in which they are sold to make it possible for a producer to be given premarket approval by the FDA to sell a dental device such as 5. A dental restorative material without the device being approved by the ADA in accordance with the specification or Acceptance Program requirements Nevertheless, these agencies are becoming increasingly dependent on one another to ensure that all products marketed worldwide are safe and effective 6. Standard ? A Swiss physician and alchemist, formulated a revolutionary principle that have remained an integral pat of the current field of toxicology. He stated that "all substances are poisons, there is none which is not a poison The right dose differentiates a poison from a remedy." (Gallo and Doull, 1991) 7. Safety No dental device (including restorative materials) is absolutely safe Safety is relative and the selection and use of dental devices or materials are based on the assumption that the benefits of such use far outweigh the known biological risks 8. Safety in dentistry Munksgaard (1992) concluded that occupa- tional risks in dentistry are low and that patients risk for side effects of dental treatment is extremely low Adverse reactions to dental materials have been reported to occur in only 0.14% of a general patient population (Kallus and Mjor, 1931) and in 0.33% of a prosthetic patient population (Hensten-Pettersen and jacobsen, 1331) 9. What cause this safety Advance in the knowledge of dental materials and their manipulation began in 1919. [during that year the U.S. Army requested the National Bureau of Standards (now known as the National Institute of Standards and Technology [NIST]) to set up specifications 10. for the evaluation and selection of dental amalgams for use in federal service This research was done under the leadership of Wilmer Souder, and an excellent report on this study was published in 1920 The information contained in the Souder report was received enthusiastically, by the dental profession, and similar testing data were then requested for other dental materials 11. At that time, the U.S. government could not allocate sufficient funds to contribute the work, so a fellowship was created and supported by the Weinstein Research Laboratories under such an arrangement, the sponsor provided money for the salaries of research associates and a certain amount of equipment and supplies. 12. The associates then worked in the National Bureau of Standards under the direction of the staff members. For all practical purposes, these associates were members of the staff supported by private interests All findings were published and became common property under this particular arrangement. Working under Dr. Souder's direction 13. Several research associates investigated the properties of dental wrought gold materials, casting gold alloys, and accessory casting materials This phase of the work resulted in the publication of an extensive and valuable research report In 1328, the Dental Research fellowship at the National Bureau of Standards was assumed by the American Dental Association (ADA) 14. The research carried out by the ADA research associates in conjunction with the staff members of NIST has been of inestimable value to the dental profession, and it has earned for this group an international reputation Researchers such as Wilmer Soudr George C Paflenbargel and William T Sweeney will undoubtedly be remembered historically as the pioneers whose work began a new era of intense research in the Geld of dental materials 15. The work at the American Dental Association (ADA) is divided into a number of categories, including the measurement of the clinically significant physical and chemical properties of dental materials and the development of new materials, instruments, and test methods Until 1365, one of the primary objectives of the facility at NlST was to formulate standards or specifications for dental materials 16. However, when the ADA Council on Dental Materials and Devices (now known as the Council on Scientific Affairs) was established in 1966, it assumed responsibility for standards development and initiated the certification of products that meet the requirements of these specifications. 17. Such specifications are standards by which the quality and properties of particular dental materials can be gauged These standards identify the requirements for the physical and chemical properties of a material that ensure satisfactory performance if the material is properly manipulated and used by the dental laboratory technician and the dentist 18. The Acceptance program of the Council on Scientific Affairs incorporates these specifications in the evaluation of dental products, and the products are tested for compliance with specification requirements When a product is classified as Accepted the manufacturer is permitted to signify on the label of the product the notation "ADA Accepted." 19. The ADA, accredited by the American National Standards Institute (ANSI), is also the administrative sponsor of two standards formulating committees operating under the direction of ANSI The ADA Standards Committee for Dental products (SCDP) develops specifications for all dental materials, instruments, and equipment, with the exception of drugs and x-ray films 20. The Council on Scientific Affairs (CSA) is also responsible for the evaluation of drugs, tooth cleaning and tooth whitening agents therapeutic agents used in dentistry, dental equipment, and dental x-ray film Working groups of ADA SCDP formulate the specifications When a specification has been approved by the ADA SCDP and the ADA CSA, it is submitted to the American National Standards Institute 21. On acceptance by that body it becomes an American National Standard thus the Council on Scientific Affairs also has the opportunity of accepting it as an ADA specification New specifications are continually being developed to apply to new program areas 22. existing specifications are periodically revised to reflect changes in product formulations new knowledge about the behavior of materials in the oral cavity for example the ANSI/ADA Specification No. 1 for dental amalgam which was revised in January 2003 23. A disturbing question If there is a change in the manufacturer or distributor of a product the period of acceptance expires automatically Why distributer is so important while their role is only restricted to the sale of material ? 24. Other regulating agencies On May 28, 1976, legislation was signed into law that gave the U.S. Food and Drug Administration (FDA) the regulatory authority to protect the public from hazardous or ineffective medical and dental devices Some dental products, such as those containing fluoride, are considered drugs but most products used in the dental clinic are considered to be devices and thus they are subject to control by the FDA 25. The classification of all medical and dental items were developed by panels composed of nongovernmental dental experts as well as representatives from industry and consumer groups the Dental Products Panel identifies any known hazards or problems associated with a device and then categorizes the item into one of three classification groups based on relative risk factor 26. Class I devices are considered to be of low risk and they are subject to general controls including the registration of the manufacturer's products adherence to good manufacturing Practices and certain record keeping requirements If it Is deemed that such general controls are not in themselves adequate to ensure safety and effectiveness as claimed by the manufacturer the item is placed into the category of Class II devices 27. Class 111 the most stringent category acquires that devices be approved for safety and effectiveness before they are marketed All implanted or life-supporting devices are placed in this premarket clearance category 28. Other countries have national government agencies comparable to the FDA that also include dental materials and devices within the jurisdiction of their regulatory authority 29. INTERNATIONAL STANDARDS Two organizations, the Federation Dentaire Internationale (FDI) and the International Organization for Standardization (ISO), are working toward the establishment of specifications for dental materials on an international level FDI initiated and actively supported a program for the formulation of international specifications for dental materials. As a result of that activity, several specifications for dental materials and devices have been adopted. 30. The IS0 is an international, nongovernmental organization whose objective is the development of international standards. This body is composed of national standards organizations from more than 80 countries The American National Standards Institute is the U.S. member. A request by the FDI to the IS0 that they consider FDI specifications for dental materials as IS0 standards led to the formation of an IS0 technical committee (TC), 7'C 106-Dentistry The responsibility of this committee is to standardize terminology and test methods and to develop standards (specifications) for dental materials, instruments, appliances, and equipment 31. Several FDI specifications have now been adopted as IS0 standards Since 1963 more than 100 new standards have been developed of are currently under development in IS0 TC 106 through cooperative programs with the FDI Thus considerable progress has already been realized in achieving the ultimate goal of a broad range of international specifications for dental materials and devices 32. The benefit of such specifications to the dental profession has been invaluable considering the worldwide supply and demand for dental materials instruments and devices Dentists are provided with criteria for selection that are impartial and reliable 33. How Are IS0 Standards Developed? Manufacturers, dental vendors, users, consumer groups, testing laboratories, governments, the dental profession, and research organizations provide input information and requirements for the development of standards. International standardization is market driven and is based on voluntary involvement of all interests in the marketplace. 34. OTHER DENTAL STANDARDS ORGANIZATIONS The work at he National lnstitute of Standards and technology in Gaithersburg Maryland has stimulated comparable programs in other countries. The Australian Dental Standards Laboratory was established in 1936 (until 1973 this facility was known as the Commonwealth Bureau of Dental Standards) 35. Other countries that have comparable organizations for developing standards and certifying products are Canada Japan France Czech Republic Germany Hungary Israel India Poland and South Africa NlOM (Nordisk Institutt for Odontologisk Materialprovning) by agreement among the governments of Denmark Finland Iceland Norway and Sweden the Scandinavian Institute of Dental Materials better known as was established in 1369 for testing certification and research regarding dental materials and equipment to be used in the five countries NlOM became operational in 1973 36. in Europe, the Comite Europeen de Normalisation (CEN) established Task Group 55 to develop European standards. After the establishment of the European Economic Community the CEN was given the charge to outline recomendations of standards for medical devices, including dental materials 37. The CE marking on product labels denotes the European mark of conformity with the Essential Requirements in the Medical device directive that became effective on January 1 1995 All medical devices marketed in the European Union countries must have the CE mark of conformity 38. some countries may enforce their own standards other countries or the international community have not developed mutually acceptable requirements For example Sweden restricts the use of nickel in cast dental alloys because of biocompatibility concerns whereas no such restriction applies to those alloys in the United States Iceland Liechtenstein,and Norway 39. Thank you