A presentation about standars of dental materials for students and researchers

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

7. 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)

9. 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

10. 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)

11. 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

12.  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

13.  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.

14.  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

15.  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)

16.  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

17.  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

18.  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.

19.  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

20.  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."

21.  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

22.  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

23.  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

24.  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

25. 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 ?

27. 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

28.  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

29.  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

30.  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

31.  Other countries have national government agencies
comparable to the FDA that also include dental
materials and devices within the jurisdiction of their
regulatory authority

33. 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.

34.  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

35.  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

36.  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

37. 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.

38. 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)

39.  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

40.  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

41.  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

42.  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

44. Thank you