for Students of B D S

1. Dr mumtaz ul islam
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Evaluation of the safety and effectiveness of dental
materials
A uniform method for manipulation of dental materials
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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.
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Relative term
No material is absolutely safe each and every dental
material have some disadvantages
Safety means benefits are more than other effects
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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
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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
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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
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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
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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
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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
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