REPORTS OF COUNCILS AND BUREAUS Expansion of the Acceptance Program for Dental Materials and Devices: alloys for cast dental restorative and prosthetic devices Council on Dental Materials and Devices
The Acceptance Program for dental materials and devices and the general guidelines, adopted by the Council for submission of any product, have been reported in t h e j o u r n a l (88:615 March 1974). A t its April 1976 meeting, the Council included alloys for cast dental restora tive and prosthetic devices in its Acceptance Program. The Acceptance Program for alloys for cast dental restorative and prosthetic devices is essen tially identical to the two Acceptance Programs currently in effect for base metal and silverpalladium alloys. This program is intended to bring under one program all the alloys used for cast dental restorations that are not under an ex isting A D A Specification. This Acceptance Pro gram is intended to include the widely used socalled “ economy golds” and to supersede the two separate programs for base metal and Ag-Pd alloys. Since the end uses of the three alloy categories are the same, a single Acceptance Program is more desirable both from the Council’s and the manufacturer’s points of view. This Acceptance Program specifically ex cludes alloys that come under the two existing A D A Specifications N os. 5 and 14 for dental casting gold alloys and dental chromium cobalt casting alloys respectively. Three principal categories of alloys are intend ed to be covered by these guidelines: base metal alloys, palladium-silver alloys, and the so-called “ economy gold” alloys. It is recognized that certain multicomponent alloys may be difficult to precisely categorize 1188 ■ JADA, Vol. 93, December 1976
in any one o f the above categories. However, it is the intent of the Council to accept alloys that have been proven to be biologically safe and clin ically effective irrespective o f their composition. ■ G u idelin es fo r subm ission o f alloys fo r c a st den ta l resto ra tive a n d p ro sth etic d e vice s: A company seeking classification o f its product under the Acceptance Program will be required to comply with the requirements of the general guidelines for submission of products, as well as with these specific guidelines for the material. A. For classification of cast restorative and prosthetic alloys in dentistry, the submission must show that the material submitted meets these product specifications and includes the other information specified. 1. The following mechanical and physical properties and the method by which they are de termined are required: a. Melting range or the liquidus temper ature. b. Casting temperature. c. Coefficient of thermal expansion. d. Thermal conductivity (optional). e. Ultimate tensile strength of cast speci mens in kg/cm2. f. Yield strength (specify offset). g. Modulus o f elasticity o f kg/cm2. h. Hardness on Rockwell 30N or Vickers scale. i. Percentage elongation (specify gauge length). j. Porcelain-metal bond strength for al loys intended as porcelain substrate.
Results o f other tests, in addition to those men tioned, may be submitted in support o f specific claims or to show the suitability of the alloy for the intended use. Examples of such tests are: Sag test during a porcelain firing cycle; immer sion type corrosion tests; potentiostatic polar ization type corrosion tests; microstructures; grain size; and so forth. 2. Evidence of safety and usefulness of product based on clinical and laboratory evalua tions. 3. Adequate instructions for handling the alloy should be submitted. This should include the melting and pouring temperature, the type o f investment, the burn out temperature of the investment, the recommended heat treatment cycle, and so forth. 4. The composition o f the alloy shall be provided on the label or on package inserts and shall include the following information: the per cent weight of each o f the three major compon ents; the percent weight o f each o f any noble
metals present, if not one o f the three major com ponents; and the percentage of each o f any hazar dous element such as lead, beryllium, and cad mium. 5. Comparisons to certified gold casting al loys within the scope o f A D A Specification N o. 5 should not be made except for comparison to the manufacturers’ own product. B. Cautions. If the product contains beryllium, this fact must be clearly marked on the immediate pack age and the instruction sheet together with in structions indicating the Occupational Safety and Health A ct recommendations for handling o f beryllium containing alloys. The Council has established the effective date for classification o f products under these guide lines as one year from the date o f this announce ment (December 1977). After that date, classifi cation of a product will be required before pro motion or exhibition through A ssociation media.
REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 93, December 1976 ■ 1189
The Acceptance Program for dental materials and devices and the general guidelines, adopted by the Council for submission of any product, have been reported in t h e j o u r n a l (88:615 March 1974). A t its April 1976 meeting, the Council included alloys for cast dental restora tive and prosthetic devices in its Acceptance Program. The Acceptance Program for alloys for cast dental restorative and prosthetic devices is essen tially identical to the two Acceptance Programs currently in effect for base metal and silverpalladium alloys. This program is intended to bring under one program all the alloys used for cast dental restorations that are not under an ex isting A D A Specification. This Acceptance Pro gram is intended to include the widely used socalled “ economy golds” and to supersede the two separate programs for base metal and Ag-Pd alloys. Since the end uses of the three alloy categories are the same, a single Acceptance Program is more desirable both from the Council’s and the manufacturer’s points of view. This Acceptance Program specifically ex cludes alloys that come under the two existing A D A Specifications N os. 5 and 14 for dental casting gold alloys and dental chromium cobalt casting alloys respectively. Three principal categories of alloys are intend ed to be covered by these guidelines: base metal alloys, palladium-silver alloys, and the so-called “ economy gold” alloys. It is recognized that certain multicomponent alloys may be difficult to precisely categorize 1188 ■ JADA, Vol. 93, December 1976
in any one o f the above categories. However, it is the intent of the Council to accept alloys that have been proven to be biologically safe and clin ically effective irrespective o f their composition. ■ G u idelin es fo r subm ission o f alloys fo r c a st den ta l resto ra tive a n d p ro sth etic d e vice s: A company seeking classification o f its product under the Acceptance Program will be required to comply with the requirements of the general guidelines for submission of products, as well as with these specific guidelines for the material. A. For classification of cast restorative and prosthetic alloys in dentistry, the submission must show that the material submitted meets these product specifications and includes the other information specified. 1. The following mechanical and physical properties and the method by which they are de termined are required: a. Melting range or the liquidus temper ature. b. Casting temperature. c. Coefficient of thermal expansion. d. Thermal conductivity (optional). e. Ultimate tensile strength of cast speci mens in kg/cm2. f. Yield strength (specify offset). g. Modulus o f elasticity o f kg/cm2. h. Hardness on Rockwell 30N or Vickers scale. i. Percentage elongation (specify gauge length). j. Porcelain-metal bond strength for al loys intended as porcelain substrate.
Results o f other tests, in addition to those men tioned, may be submitted in support o f specific claims or to show the suitability of the alloy for the intended use. Examples of such tests are: Sag test during a porcelain firing cycle; immer sion type corrosion tests; potentiostatic polar ization type corrosion tests; microstructures; grain size; and so forth. 2. Evidence of safety and usefulness of product based on clinical and laboratory evalua tions. 3. Adequate instructions for handling the alloy should be submitted. This should include the melting and pouring temperature, the type o f investment, the burn out temperature of the investment, the recommended heat treatment cycle, and so forth. 4. The composition o f the alloy shall be provided on the label or on package inserts and shall include the following information: the per cent weight of each o f the three major compon ents; the percent weight o f each o f any noble
metals present, if not one o f the three major com ponents; and the percentage of each o f any hazar dous element such as lead, beryllium, and cad mium. 5. Comparisons to certified gold casting al loys within the scope o f A D A Specification N o. 5 should not be made except for comparison to the manufacturers’ own product. B. Cautions. If the product contains beryllium, this fact must be clearly marked on the immediate pack age and the instruction sheet together with in structions indicating the Occupational Safety and Health A ct recommendations for handling o f beryllium containing alloys. The Council has established the effective date for classification o f products under these guide lines as one year from the date o f this announce ment (December 1977). After that date, classifi cation of a product will be required before pro motion or exhibition through A ssociation media.
REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 93, December 1976 ■ 1189
