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Additions to the List of Classified Composite Restorative Materials
R E P O R T S
A d d it io n s
to
R e s t o r a t iv e
O F
t h e
C O U N C IL S
L ist
o f
C la s s if ie d
A N D
B U R E A U S
C o m p o s it e
M a te r ia ls
Council on Dental Materials and Devices
The acceptance and classification program of the Council on Dental Materials and D evices is described in “ Evaluation Programs” in the Guide to D ental M aterials and Devices. The Council’s program provides for a classification of Acceptable, Provisionally Acceptable, or U n acceptable. Information regarding the expan sion o f acceptance programs to include the com posite restorative materials appeared in the Feb ruary 1972 issue o f t h e j o u r n a l . The acceptance program of the Council ap plies to materials and devices for which evidence o f safety and usefulness has been established by biological, laboratory, and/or clinical evalua tion where appropriate. The Council initiated an acceptance program to serve as an ad-interim evaluation of such products as composite re storative materials until a physical specifica tion can be developed. Initially the Council recognized the principal usefulness of the composite restorative mater ials as being effective in Class III and Class V restorations. They were also recognized to have limited application in Class IV properly pinned restorations and in Class I restorations in pre molars where esthetics was of primary impor tance. A s a result o f the Council’s continuing review of its guidelines for acceptance programs and its desire to keep all requirements comparable to current recognized clinical practices, the Council at its meeting N ov 30 to D ec 1, 1972 424 ■ JADA, Vol. 86, February 1973
modified that portion of the foregoing related to the use of composites in Class I and Class IV applications. The Council now will recognize claims, if clinical documentation is submitted, for the use of composites in selected Class IV restorations without the use of pins. The Coun cil reviewed the use o f composite restorative materials in Class II applications and is o f the opinion that sufficient clinical evidence is still not available to warrant recognition o f such ap plications. At the recent Council meeting, the following classifications of composite materials were granted:
ACCEPTABLE
Adaptic
Johnson & Johnson
On the basis of the evidence presented by Johnson & John son and consultant recommendations, the Council classi fied Adaptic as Acceptable for the usual three-year period. The manufacturer may use the following statement in future labeling and promotional material to indicate Council clas sification: Adaptic composite restorative material is Acceptable for use in Class III and Class V restorations and for use in selected Class I and in selected Class IV restor ations where esthetics is of primary importance. Council on Dental Materials and Devices American Dental Association
Restodent
PROVISIONALLY ACCEPTABLE
Lee Pharmaceuticals
Nuva-Fil
L. D. Caulk Co., Div. o f Dentsply International, Inc.
After review of the evidence submitted by the L. D. Caulk Co. and recommendations of the consultants, the Council classified Nuva-Fil as Provisionally Acceptable. The manu facturers may use the following statement in future adver tising and labeling: Nuva-Fil composite restorative material is Provision ally Acceptable for use in Class III and Class V res torations and for use in selected Class I and in select ed Class IV restorations where esthetics is of primary importance. Council on Dental Materials and Devices American Dental Association
V is c o - G e l a s
T r e a t m e n t
P r o v is io n a lly
R e lin e r
On review of the submissions and consultant recommenda tions, the Council classified Restodent as Provisionally Acceptable. The following statement may be used by the manufacturers in future labeling and promotional material. Restodent composite restorative material is Provision ally Acceptable for use in Class III and Class V restora tions and for use in selected Class I and in selected Class IV restorations where esthetics is of primary im portance. Council on Dental Materials and Devices American Dental Association
Classification in the Provisionally Acceptable category is reviewed each year and is not ordi narily continued for more than three years. The Council will, at any time, consider any addition al evidence from recent clinical studies to sup port a request for a change in classification to the Acceptable category.
M a te r ia l
c la s s if ie d
A c c e p t a b l e
Council on Dental Materials and Devices
The acceptance and classification program of the Council on Dental Materials and D evices is described in “ Evaluation Programs” in the Guide to D ental M aterials and D evices. The Council’s program provides for a classification of Acceptable, Provisionally Acceptable, or U n acceptable. Information regarding the expan sion of acceptance programs to include the treat ment relining materials appeared in the Febru ary 1972 issue o f t h e j o u r n a l . Claudius Ash Inc. of N ew York has submit ted their treatment reliner, Visco-G el, for con sideration by the Council. On the basis of the evidence presented and consultant recommen dations, the Council has classified Visco-G el as Provisionally Acceptable. Classification of the product means at the time of its considera tion, V isco-G el conformed with the provisions for acceptance established by the Council on Dental Materials and D evices. Classification in the Provisionally Accept able category is reviewed each year and is not
ordinarily continued for more than three years. The Council will, at any time, consider any ad ditional evidence from recent clinical studies to support a request for a change in classification to the Acceptable category. The manufacturer may use the following statement in future label ing and promotional material to indicate Coun cil classification:
V isco-G el is Provisionally Acceptable as a tempor ary measure in selected patients during the tissue treatment period. All treatment materials must be changed frequently—periodic examination is recom mended. Council on Dental Materials and D evices American Dental A ssociation
The Council welcom es continued comments or suggestions on this or any other phase of the Council’s programs and activities.
REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 86, February 1973 ■ 425
A d d it io n s
to
R e s t o r a t iv e
O F
t h e
C O U N C IL S
L ist
o f
C la s s if ie d
A N D
B U R E A U S
C o m p o s it e
M a te r ia ls
Council on Dental Materials and Devices
The acceptance and classification program of the Council on Dental Materials and D evices is described in “ Evaluation Programs” in the Guide to D ental M aterials and Devices. The Council’s program provides for a classification of Acceptable, Provisionally Acceptable, or U n acceptable. Information regarding the expan sion o f acceptance programs to include the com posite restorative materials appeared in the Feb ruary 1972 issue o f t h e j o u r n a l . The acceptance program of the Council ap plies to materials and devices for which evidence o f safety and usefulness has been established by biological, laboratory, and/or clinical evalua tion where appropriate. The Council initiated an acceptance program to serve as an ad-interim evaluation of such products as composite re storative materials until a physical specifica tion can be developed. Initially the Council recognized the principal usefulness of the composite restorative mater ials as being effective in Class III and Class V restorations. They were also recognized to have limited application in Class IV properly pinned restorations and in Class I restorations in pre molars where esthetics was of primary impor tance. A s a result o f the Council’s continuing review of its guidelines for acceptance programs and its desire to keep all requirements comparable to current recognized clinical practices, the Council at its meeting N ov 30 to D ec 1, 1972 424 ■ JADA, Vol. 86, February 1973
modified that portion of the foregoing related to the use of composites in Class I and Class IV applications. The Council now will recognize claims, if clinical documentation is submitted, for the use of composites in selected Class IV restorations without the use of pins. The Coun cil reviewed the use o f composite restorative materials in Class II applications and is o f the opinion that sufficient clinical evidence is still not available to warrant recognition o f such ap plications. At the recent Council meeting, the following classifications of composite materials were granted:
ACCEPTABLE
Adaptic
Johnson & Johnson
On the basis of the evidence presented by Johnson & John son and consultant recommendations, the Council classi fied Adaptic as Acceptable for the usual three-year period. The manufacturer may use the following statement in future labeling and promotional material to indicate Council clas sification: Adaptic composite restorative material is Acceptable for use in Class III and Class V restorations and for use in selected Class I and in selected Class IV restor ations where esthetics is of primary importance. Council on Dental Materials and Devices American Dental Association
Restodent
PROVISIONALLY ACCEPTABLE
Lee Pharmaceuticals
Nuva-Fil
L. D. Caulk Co., Div. o f Dentsply International, Inc.
After review of the evidence submitted by the L. D. Caulk Co. and recommendations of the consultants, the Council classified Nuva-Fil as Provisionally Acceptable. The manu facturers may use the following statement in future adver tising and labeling: Nuva-Fil composite restorative material is Provision ally Acceptable for use in Class III and Class V res torations and for use in selected Class I and in select ed Class IV restorations where esthetics is of primary importance. Council on Dental Materials and Devices American Dental Association
V is c o - G e l a s
T r e a t m e n t
P r o v is io n a lly
R e lin e r
On review of the submissions and consultant recommenda tions, the Council classified Restodent as Provisionally Acceptable. The following statement may be used by the manufacturers in future labeling and promotional material. Restodent composite restorative material is Provision ally Acceptable for use in Class III and Class V restora tions and for use in selected Class I and in selected Class IV restorations where esthetics is of primary im portance. Council on Dental Materials and Devices American Dental Association
Classification in the Provisionally Acceptable category is reviewed each year and is not ordi narily continued for more than three years. The Council will, at any time, consider any addition al evidence from recent clinical studies to sup port a request for a change in classification to the Acceptable category.
M a te r ia l
c la s s if ie d
A c c e p t a b l e
Council on Dental Materials and Devices
The acceptance and classification program of the Council on Dental Materials and D evices is described in “ Evaluation Programs” in the Guide to D ental M aterials and D evices. The Council’s program provides for a classification of Acceptable, Provisionally Acceptable, or U n acceptable. Information regarding the expan sion of acceptance programs to include the treat ment relining materials appeared in the Febru ary 1972 issue o f t h e j o u r n a l . Claudius Ash Inc. of N ew York has submit ted their treatment reliner, Visco-G el, for con sideration by the Council. On the basis of the evidence presented and consultant recommen dations, the Council has classified Visco-G el as Provisionally Acceptable. Classification of the product means at the time of its considera tion, V isco-G el conformed with the provisions for acceptance established by the Council on Dental Materials and D evices. Classification in the Provisionally Accept able category is reviewed each year and is not
ordinarily continued for more than three years. The Council will, at any time, consider any ad ditional evidence from recent clinical studies to support a request for a change in classification to the Acceptable category. The manufacturer may use the following statement in future label ing and promotional material to indicate Coun cil classification:
V isco-G el is Provisionally Acceptable as a tempor ary measure in selected patients during the tissue treatment period. All treatment materials must be changed frequently—periodic examination is recom mended. Council on Dental Materials and D evices American Dental A ssociation
The Council welcom es continued comments or suggestions on this or any other phase of the Council’s programs and activities.
REPORTS OF COUNCILS AND BUREAUS / JADA, Vol. 86, February 1973 ■ 425