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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