Dr mumtaz ul islam

9 November 2013

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Evaluation of the safety and effectiveness of dental
materials
A uniform method for manipulation of dental materials...


Paracelsus (1493-1540) a Swiss physician and
alchemist, formulated a revolutionary principle that
have remained an inte...





Relative term
No material is absolutely safe each and every dental
material have some disadvantages
Safety means b...
9 November 2013

9
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Dentists and patients are more protected as well as
more exposed to infections
Safety will be assured by strictly...




Advancement in the knowledge of dental materials and
their manipulation began in 1919. during that year the
U.S. Arm...






This research was done under the leadership of Wilmer
Souder, and an excellent report on this study was
published...

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

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There were no funds with the government
A fellowship was created and supported by the
Weinstein Research Labora...






Several research associates investigated the properties
of dental wrought gold materials, casting gold alloys,
an...
9 November 2013

15
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Until 1965, one of the primary objectives of the
facility at NlST was to formulate standards or
specifications for d...
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The research carried out by the ADA research
associates in conjunction with the staff members of
NIST has been of ...
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ADA Council on Dental Materials and Devices (now
known as the Council on Scientific Affairs) was
established i...
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

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The Council on Scientific Affairs (CSA) is also
responsible for the evaluation of drugs, tooth cleaning
and tooth...


Specifications are periodically revised to reflect
changes in product formulations new knowledge about
the behavior of ...


U.S. Food and Drug Administration (FDA) the
regulatory authority to protect the public from
hazardous or ineffective me...
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Class 1
Generals measures application during manufacturing
low risk materials
Class 2
General measures if ...
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Federation Dentaire Internationale (FDI)
International Organization for Standardization (ISO)
The IS0 is an interna...
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Manufacturers, dental vendors, users, consumer groups,
testing laboratories, governments, the dental
profession, and re...
9 November 2013

25
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The work at he National lnstitute of Standards and
technology in Gaithersburg Maryland has stimulated
comparable pro...
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Other countries that have comparable organizations for
developing standards and certifying products are
Canada...
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

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Europe, the Comite Europeen de Normalisation (CEN)
The CE marking on product labels denotes the
European mark of c...



Some countries may enforce their own standards
Other countries or the international community have
not developed mutu...
9 November 2013

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Standards for dental dr mumtaz ul islam

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Standards for dental dr mumtaz ul islam

  1. 1. Dr mumtaz ul islam 9 November 2013 1
  2. 2. 9 November 2013 2
  3. 3. 9 November 2013 3
  4. 4. 9 November 2013 4
  5. 5. 9 November 2013 5
  6. 6.   Evaluation of the safety and effectiveness of dental materials A uniform method for manipulation of dental materials 9 November 2013 6
  7. 7.  Paracelsus (1493-1540) a Swiss physician and alchemist, formulated a revolutionary principle that have remained an integral part 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.” Source: Gallo and Doull, 1991. 9 November 2013 7
  8. 8.    Relative term No material is absolutely safe each and every dental material have some disadvantages Safety means benefits are more than other effects 9 November 2013 8
  9. 9. 9 November 2013 9
  10. 10.    Dentists and patients are more protected as well as more exposed to infections Safety will be assured by strictly adherence with the safety standards Safety ,durability and efficacy of dental materials can be enjoyed by following standards and vice versa 9 November 2013 10
  11. 11.   Advancement 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) For dental amalgam which will be used for federal services 9 November 2013 11
  12. 12.    This research was done under the leadership of Wilmer Souder, and an excellent report on this study was published in 1920 The contents of the Souder report was received enthusiastically by the dental profession Similar testing data were then requested for other dental materials 9 November 2013 12
  13. 13.     There were no funds with the government A fellowship was created and supported by the Weinstein Research Laboratories Sponsors have to pay the expenditure Dr sauder was the supervisor of the committee 9 November 2013 13
  14. 14.    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 1928 Researchers such as Wilmer Soudr, George C Paflenbargel and William T Sweeney will undoubtedly be remembered historically as the pioneers 9 November 2013 14
  15. 15. 9 November 2013 15
  16. 16.   Until 1965, one of the primary objectives of the facility at NlST was to formulate standards or specifications for dental materials In 1928, the Dental Research fellowship at the National Bureau of Standards was assumed by the American Dental Association (ADA) 9 November 2013 16
  17. 17.    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 Now researches were made for ADA Until 1965, the primary objectives of the NlST was to formulate standards or specifications for dental materials 9 November 2013 17
  18. 18.     ADA Council on Dental Materials and Devices (now known as the Council on Scientific Affairs) was established in 1966 On acceptance of a material by ADA manufacturers were allowed to use ADA mark on their products The ADA, accredited by the American National Standards Institute (ANSI) The ADA Standards Committee for Dental products (SCDP) develops specifications for all dental materials 9 November 2013 18
  19. 19.    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 When a specification has been approved by the ADA SCDP and the ADA CSA, it is submitted to the American National Standards Institute On acceptance by that body it becomes an American National Standard 9 November 2013 19
  20. 20.  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 9 November 2013 20
  21. 21.  U.S. Food and Drug Administration (FDA) the regulatory authority to protect the public from hazardous or ineffective medical and dental devices on May 28, 1976 9 November 2013 21
  22. 22.        Class 1 Generals measures application during manufacturing low risk materials Class 2 General measures if not supposed to be adequate Class 3 Thorough control of safety and effectiveness prior to marketing is mandatory 9 November 2013 22
  23. 23.    Federation Dentaire Internationale (FDI) International Organization for Standardization (ISO) 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 9 November 2013 23
  24. 24.  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 9 November 2013 24
  25. 25. 9 November 2013 25
  26. 26.   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) 9 November 2013 26
  27. 27.     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 Material provning) The governments of Denmark Finland Iceland Norway and Sweden were the founders of NIOM It becomes operational in 1973 9 November 2013 27
  28. 28.    Europe, the Comite Europeen de Normalisation (CEN) The CE marking on product labels denotes the European mark of conformity All medical devices marketed in the European Union countries must have the CE mark of conformity 9 November 2013 28
  29. 29.   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 9 November 2013 29
  30. 30. 9 November 2013 30
  31. 31. 9 November 2013 31
  32. 32. 9 November 2013 32

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