REPORTS OF COUNCILS AND BUREAUS
Certification and Classification Programs for Dental Materials and Devices List of Certified Dental Materials and Devices revised to Jan 1, 1977 Council on Dental Materials and
In order to improve and maintain the standards and qualities o f certain materials and devices used in the practice of dentistry and to promote the truthful advertising and labeling of the mater ials, the American Dental Association, through its Council on Dental Materials and D evices, maintains a program for the certification of den tal materials and devices. Under this program the manufacturer of a dental material certifies that his product complies with the specifications which have been approved as official Specifica tions of the American Dental Association and that he is in compliance with the American D en tal Association Advertising and Exhibiting Stan dards. If the product is found to comply with the specifications, its name is then placed on the “ List of certified dental materials and devices” which is maintained and published periodically by the Council in t h e j o u r n a l and in the G uide to D e n ta l Materials and D evices.
P r o c e d u r e f o r s u b m it t in g
or distributor may certify a product. An import ed product may be submitted if the certification is by the United States distributor who will be responsible for the original certification as well as a testing program in the United States to show continuing compliance with the appropriate specification. Certifications must be accom panied by the following information and such other data as may be requested by the Council from time to time: (1) the trade name; (2) the serial or lot number; (3) the year and month of manufacture; (4) the physical properties as ob tained by standard test methods with a brief de scription of the apparatus used in making the tests if different from that described in the speci fication; (5) data covering every provision of the official specification with names of the observ ers and the dates of the tests; and (6) specimens of all labels, guarantees, and instructions that are used in connection with the product.
M a n u f a c t u r e r ’s a g r e e m e n t
a c e r t if ic a t io n
The A ssociation’s Certification Program applies only to products that are sold generally in the United States of America, and any manufacturer
In certifying a product, the manufacturer shall agree (1) that tests will be made regularly by the manufacturer to determine the continuing com pliance of the material with the official specificaJADA, Vol. 94, January 1977 ■ 135
tion; (2) that records of such tests shall be sup plied as requested by thé Council; (3) that test records and data for any batch of a certified prod uct shall be made available to the Council on re quest; (4) that a representative o f the Council, on request, will be granted the right to inspect the testing equipment of the manufacturer; (5) that immediate notification shall be given the Coun cil when the composition or the design o f any product on the “ List of Certified Dental Mater ials and D evices” is changed; (6) that all package inserts and promotional material shall be sub mitted to the Council for review to ensure com pliance with the Advertising and Exhibiting Standards of the Association; (7) that in labeling and promotional material reference to the certi fied status o f the product shall be limited to the conditions stipulated in the section entitled “ An nouncement and maintenance of certification” ; (8) that no unauthorized reference will be made to the Specifications and Certification Programs of the Association in labeling, advertising, or other promotional material for any of their other prod ucts which are eligible for certification; and (9) that if the certification is rejected or if accept ance o f the certification is withdrawn, the manu facturer shall discontinue use of any statement connecting the product with the American D en tal Association within six months of the date of notification of the firm by the Council.
Testing of products certified by manufacturers Prior to the acceptance of a manufacturer’s cer tification for any product, it will be tested for compliance with the specification by the Amer ican Dental Association. Test samples, unless otherwise indicated in specific specifications, will be procured on the open market at the expense o f the manufacturer. In the case of noble metals, any scrap remaining after the completion o f the tests will be returned to the manufacturer.
name of the product will be placed on the “ List o f certified dental materials and d evices.” F ol lowing such announcement, the manufacturer may appropriately indicate in promotional ma terial and labeling that the product complies with an official specification only by inclusion of the following statement: “ This product appears on the American Dental A s sociation List o f Certified Dental Materials and D e v ices.”
The Council may, however, permit the use of the following statement during the period from the time of receipt of a certification by the Coun cil until such time as that certification is either accepted or rejected: “ Certification with American Dental Association pending.”
The unauthorized use of either of the statements will subject the manufacturer to the usual legal responsibilities. From time to time, the Council will publish in t h e j o u r n a l and in other appropriate publica tions, the “ List o f certified dental materials and devices” and notices o f voluntary withdrawals o f certified products from the list by their respec tive manufacturers. If there is a change in manufacturer or dis tributor o f a certified product, the acceptance of the certification by the Council expires auto matically. The product may then be resubmit ted as a new certification.
Responsibility for guarantee of compliance The responsibility for guaranteeing that a prod uct complies with an official specification lies solely with the manufacturer who certified the product and not with the American Dental A sso ciation.
Announcement and maintenance of certification If a product is found to comply with an official specification of the American Dental Associa tion, announcement of acceptance o f the certi fication will be made by the Council and the
Promotional material Claims made for products in labeling, advertis ing, or by any other means shall be clear and ac curate and shall not result in the disparagement o f other useful products or useful techniques available for similar purposes. Advertisements
136 ■ REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 94, January 1977
to the dental profession or to the public shall not include misleading or unwarranted statements. Advertising and exhibit of accepted products shall be in compliance with the Advertising and Exhibiting Standards o f the American Dental Association.
Resurvey of certified products A t any time and without notice to the manufac turer, the Council may authorize the testing of any or all products on the “ List of certified den tal materials and d evices.” In the event that a
sample fails to comply with the respective speci fication, the material will be removed from the “ List o f certified dental materials and d evices.” Test samples will be produced at the expense of the manufacturer as outlined in the section en titled: “ Testing of products certified by manu facturers.” In the event that a product is removed from the “ List of certified dental materials and de v ices,” the manufacturer may subsequently recertify the product provided acceptable evi dence is given that the product which did not comply with the specification has been removed from the market.
CERTIFIED ALLOYS FOR DENTAL AMALGAM ADA Specification No. 1, second revision
A cculoy, Zinc; Non-Zinc, Litton D ental Products Accusphere, Zinc; Non-Zinc, Litton D ental Products Amalcap, H . D .Ju s tiC o ., Div. ofW illiams G old Refining Co., Inc. Argentum “ A ” ; Micro-Fine Cut; Micro Non-Zinc; Micro Special, H am m ond D ental Mfg. Co. Aristaloy, Baker D ental Dept, o f Engelhard Industries, Engelhard Minerals & Chemicals Corp. Aristaloy-MS, Baker D ental Dept, o f Engelhard Industries, Engelhard Minerals & Chemicals Corp. Balanced Alloy, Litton Dental Products Blue Ribbon Supreme 72% Fine Cut; 72% Micro Cut; 68%; 72% Fine Cut Non-Zinc, Rugby Laboratories, Inc. Caulk Fine Cut; Fine Cut Non-Zinc; Spherical Alloy; Micro Non-Zinc; Micro Cut, L. D . Caulk Co., Div. o f Dentsply International, Inc. Certified Non-Zinc, Teledyne Dental Products Co. Cresilver, Crescent Dental Mfg. Co. Dispersalloy Zinc; Non-Zinc, Johnson & Johnson D ental Products Co. Fellowship, J . Bird Moyer Co., Inc. Formalloy, Zinc; Non-Zinc, Weber Consumable Products, Div. o f Sterndent Corp. H & M Special, Hauser & Miller Improved 68% Fine Cut; Improved 72% Fine Cut; Micro Cut; 72% Fine Cut (Non-Zinc), Henry Schein, Inc. Kent Improved Fine Cut Filling Alloy 72%; Improved Non-Zinc 72% Fine Cut; Improved Fine Cut 68%; Micro
Cut, Stratford-Cookson Co. Kerr Spheraloy, Kerr Mfg. Co. Line Alloy, Fine Grained, Lincoln Dental Supply Co. Lustraloy, Regular; Micro Fine; Extra Fine, Pfingst
Certification and Classification Programs for Dental Materials and Devices List of Certified Dental Materials and Devices revised to Jan 1, 1977 Council on Dental Materials and
In order to improve and maintain the standards and qualities o f certain materials and devices used in the practice of dentistry and to promote the truthful advertising and labeling of the mater ials, the American Dental Association, through its Council on Dental Materials and D evices, maintains a program for the certification of den tal materials and devices. Under this program the manufacturer of a dental material certifies that his product complies with the specifications which have been approved as official Specifica tions of the American Dental Association and that he is in compliance with the American D en tal Association Advertising and Exhibiting Stan dards. If the product is found to comply with the specifications, its name is then placed on the “ List of certified dental materials and devices” which is maintained and published periodically by the Council in t h e j o u r n a l and in the G uide to D e n ta l Materials and D evices.
P r o c e d u r e f o r s u b m it t in g
or distributor may certify a product. An import ed product may be submitted if the certification is by the United States distributor who will be responsible for the original certification as well as a testing program in the United States to show continuing compliance with the appropriate specification. Certifications must be accom panied by the following information and such other data as may be requested by the Council from time to time: (1) the trade name; (2) the serial or lot number; (3) the year and month of manufacture; (4) the physical properties as ob tained by standard test methods with a brief de scription of the apparatus used in making the tests if different from that described in the speci fication; (5) data covering every provision of the official specification with names of the observ ers and the dates of the tests; and (6) specimens of all labels, guarantees, and instructions that are used in connection with the product.
M a n u f a c t u r e r ’s a g r e e m e n t
a c e r t if ic a t io n
The A ssociation’s Certification Program applies only to products that are sold generally in the United States of America, and any manufacturer
In certifying a product, the manufacturer shall agree (1) that tests will be made regularly by the manufacturer to determine the continuing com pliance of the material with the official specificaJADA, Vol. 94, January 1977 ■ 135
tion; (2) that records of such tests shall be sup plied as requested by thé Council; (3) that test records and data for any batch of a certified prod uct shall be made available to the Council on re quest; (4) that a representative o f the Council, on request, will be granted the right to inspect the testing equipment of the manufacturer; (5) that immediate notification shall be given the Coun cil when the composition or the design o f any product on the “ List of Certified Dental Mater ials and D evices” is changed; (6) that all package inserts and promotional material shall be sub mitted to the Council for review to ensure com pliance with the Advertising and Exhibiting Standards of the Association; (7) that in labeling and promotional material reference to the certi fied status o f the product shall be limited to the conditions stipulated in the section entitled “ An nouncement and maintenance of certification” ; (8) that no unauthorized reference will be made to the Specifications and Certification Programs of the Association in labeling, advertising, or other promotional material for any of their other prod ucts which are eligible for certification; and (9) that if the certification is rejected or if accept ance o f the certification is withdrawn, the manu facturer shall discontinue use of any statement connecting the product with the American D en tal Association within six months of the date of notification of the firm by the Council.
Testing of products certified by manufacturers Prior to the acceptance of a manufacturer’s cer tification for any product, it will be tested for compliance with the specification by the Amer ican Dental Association. Test samples, unless otherwise indicated in specific specifications, will be procured on the open market at the expense o f the manufacturer. In the case of noble metals, any scrap remaining after the completion o f the tests will be returned to the manufacturer.
name of the product will be placed on the “ List o f certified dental materials and d evices.” F ol lowing such announcement, the manufacturer may appropriately indicate in promotional ma terial and labeling that the product complies with an official specification only by inclusion of the following statement: “ This product appears on the American Dental A s sociation List o f Certified Dental Materials and D e v ices.”
The Council may, however, permit the use of the following statement during the period from the time of receipt of a certification by the Coun cil until such time as that certification is either accepted or rejected: “ Certification with American Dental Association pending.”
The unauthorized use of either of the statements will subject the manufacturer to the usual legal responsibilities. From time to time, the Council will publish in t h e j o u r n a l and in other appropriate publica tions, the “ List o f certified dental materials and devices” and notices o f voluntary withdrawals o f certified products from the list by their respec tive manufacturers. If there is a change in manufacturer or dis tributor o f a certified product, the acceptance of the certification by the Council expires auto matically. The product may then be resubmit ted as a new certification.
Responsibility for guarantee of compliance The responsibility for guaranteeing that a prod uct complies with an official specification lies solely with the manufacturer who certified the product and not with the American Dental A sso ciation.
Announcement and maintenance of certification If a product is found to comply with an official specification of the American Dental Associa tion, announcement of acceptance o f the certi fication will be made by the Council and the
Promotional material Claims made for products in labeling, advertis ing, or by any other means shall be clear and ac curate and shall not result in the disparagement o f other useful products or useful techniques available for similar purposes. Advertisements
136 ■ REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 94, January 1977
to the dental profession or to the public shall not include misleading or unwarranted statements. Advertising and exhibit of accepted products shall be in compliance with the Advertising and Exhibiting Standards o f the American Dental Association.
Resurvey of certified products A t any time and without notice to the manufac turer, the Council may authorize the testing of any or all products on the “ List of certified den tal materials and d evices.” In the event that a
sample fails to comply with the respective speci fication, the material will be removed from the “ List o f certified dental materials and d evices.” Test samples will be produced at the expense of the manufacturer as outlined in the section en titled: “ Testing of products certified by manu facturers.” In the event that a product is removed from the “ List of certified dental materials and de v ices,” the manufacturer may subsequently recertify the product provided acceptable evi dence is given that the product which did not comply with the specification has been removed from the market.
CERTIFIED ALLOYS FOR DENTAL AMALGAM ADA Specification No. 1, second revision
A cculoy, Zinc; Non-Zinc, Litton D ental Products Accusphere, Zinc; Non-Zinc, Litton D ental Products Amalcap, H . D .Ju s tiC o ., Div. ofW illiams G old Refining Co., Inc. Argentum “ A ” ; Micro-Fine Cut; Micro Non-Zinc; Micro Special, H am m ond D ental Mfg. Co. Aristaloy, Baker D ental Dept, o f Engelhard Industries, Engelhard Minerals & Chemicals Corp. Aristaloy-MS, Baker D ental Dept, o f Engelhard Industries, Engelhard Minerals & Chemicals Corp. Balanced Alloy, Litton Dental Products Blue Ribbon Supreme 72% Fine Cut; 72% Micro Cut; 68%; 72% Fine Cut Non-Zinc, Rugby Laboratories, Inc. Caulk Fine Cut; Fine Cut Non-Zinc; Spherical Alloy; Micro Non-Zinc; Micro Cut, L. D . Caulk Co., Div. o f Dentsply International, Inc. Certified Non-Zinc, Teledyne Dental Products Co. Cresilver, Crescent Dental Mfg. Co. Dispersalloy Zinc; Non-Zinc, Johnson & Johnson D ental Products Co. Fellowship, J . Bird Moyer Co., Inc. Formalloy, Zinc; Non-Zinc, Weber Consumable Products, Div. o f Sterndent Corp. H & M Special, Hauser & Miller Improved 68% Fine Cut; Improved 72% Fine Cut; Micro Cut; 72% Fine Cut (Non-Zinc), Henry Schein, Inc. Kent Improved Fine Cut Filling Alloy 72%; Improved Non-Zinc 72% Fine Cut; Improved Fine Cut 68%; Micro
Cut, Stratford-Cookson Co. Kerr Spheraloy, Kerr Mfg. Co. Line Alloy, Fine Grained, Lincoln Dental Supply Co. Lustraloy, Regular; Micro Fine; Extra Fine, Pfingst
