Directions For Use - DENTSPLY Megalloy EZ Instrucciones De Uso

Directions for Use

Megasalloy
Spherical Alloy Self-Activating Capsule
Caution: For dental use only.
In the USA: Rx only.
Megalloy EZ Spherical Alloy is a high strength, high copper, spherical alloy.
Megalloy EZ Spherical Alloy is a high strength, high copper, spherical alloy.
Megalloy ® ® EZ Spherical Alloy is a high strength, high copper, spherical alloy.
Megalloy EZ Spherical Alloy is a high strength, high copper, spherical alloy.
®
®
Megalloy EZ Spherical Alloy is a high strength, high copper, spherical alloy.
®
Megalloy EZ Spherical Alloy is a high strength, high copper, spherical alloy.
®
1. COMPOSITION
1. COMPOSITION
1. COMPOSITION
1. COMPOSITION
1. COMPOSITION
1. COMPOSITION
Alloy Powder Alloy Powder
Alloy Powder
Alloy Powder
Alloy Powder
Alloy Powder
Silver
Silver
Silver
Silver
Silver
Silver
Tin
Tin
Tin
Tin
Tin
Tin
Copper
Copper
Copper
Copper
Copper
Copper
Mercury
Mercury
Mercury
Mercury
Mercury
Mercury
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
2. INDICATION FOR USE
2. INDICATION FOR USE
2. INDICATION FOR USE
2. INDICATION FOR USE
2. INDICATION FOR USE
2. INDICATION FOR USE
Megalloy EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
Megalloy EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
®
Megalloy ® EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
Megalloy EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
®
®
Megalloy EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
®
Megalloy EZ Amalgam is designed for use in stress bearing restorations (Class 1 and 2), when other
®
restorative materials or restoration techniques are not indicated.
restorative materials or restoration techniques are not indicated.
restorative materials or restoration techniques are not indicated.
restorative materials or restoration techniques are not indicated.
restorative materials or restoration techniques are not indicated.
restorative materials or restoration techniques are not indicated.
3. CONTRAINDICATION 3. CONTRAINDICATION
3. CONTRAINDICATION
3. CONTRAINDICATION
3. CONTRAINDICATION
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of the
components.
components.
components.
components.
components.
components.
4. WARNINGS
4. WARNINGS
4. WARNINGS
4. WARNINGS
4. WARNINGS
4. WARNINGS
1. It has been suggested by the Ad-hoc working group established by the European
1. It has been suggested by the Ad-hoc working group established by the European
1. It has been suggested by the Ad-hoc working group established by the European
1. It has been suggested by the Ad-hoc working group established by the European
1. It has been suggested by the Ad-hoc working group established by the European
1. It has been suggested by the Ad-hoc working group established by the European
Commission that the following information, be kept in mind when considering the use of
Commission that the following information, be kept in mind when considering the use of
Commission that the following information, be kept in mind when considering the use of
Commission that the following information, be kept in mind when considering the use of
Commission that the following information, be kept in mind when considering the use of
Commission that the following information, be kept in mind when considering the use of
dental amalgams:
dental amalgams:
dental amalgams:
dental amalgams:
dental amalgams:
dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury concentration
• After placement or removal of dental amalgam restorations increased mercury concentration
• After placement or removal of dental amalgam restorations increased mercury concentration
• After placement or removal of dental amalgam restorations increased mercury concentration
• After placement or removal of dental amalgam restorations increased mercury concentration
• After placement or removal of dental amalgam restorations increased mercury concentration
in blood and urine has been observed. According to available scientific knowledge this
in blood and urine has been observed. According to available scientific knowledge this
in blood and urine has been observed. According to available scientific knowledge this
in blood and urine has been observed. According to available scientific knowledge this
in blood and urine has been observed. According to available scientific knowledge this
in blood and urine has been observed. According to available scientific knowledge this
increase has not been associated with any adverse health effects.
increase has not been associated with any adverse health effects.
increase has not been associated with any adverse health effects.
increase has not been associated with any adverse health effects.
increase has not been associated with any adverse health effects.
increase has not been associated with any adverse health effects.
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
• If placed in close contact with other metal restorations galvanic effects may occur. In most cases
they will be of short lasting duration. If the effect persists the user should consider replacement of
they will be of short lasting duration. If the effect persists the user should consider replacement of
they will be of short lasting duration. If the effect persists the user should consider replacement of
they will be of short lasting duration. If the effect persists the user should consider replacement of
they will be of short lasting duration. If the effect persists the user should consider replacement of
they will be of short lasting duration. If the effect persists the user should consider replacement of
the dental amalgam filling with another material.
the dental amalgam filling with another material.
the dental amalgam filling with another material.
the dental amalgam filling with another material.
the dental amalgam filling with another material.
the dental amalgam filling with another material.
• There are no proven adverse effects on the fetus associated with the placement or presence of
• There are no proven adverse effects on the fetus associated with the placement or presence of
• There are no proven adverse effects on the fetus associated with the placement or presence of
• There are no proven adverse effects on the fetus associated with the placement or presence of
• There are no proven adverse effects on the fetus associated with the placement or presence of
• There are no proven adverse effects on the fetus associated with the placement or presence of
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
dental amalgam fillings in the mother. It is sensible, however, where clinically feasible, to minimize
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
health interventions during pregnancy and avoid any unnecessary chemical exposure of the fetus.
This precaution should be observed with the use of all dental materials.
This precaution should be observed with the use of all dental materials.
This precaution should be observed with the use of all dental materials.
This precaution should be observed with the use of all dental materials.
This precaution should be observed with the use of all dental materials.
This precaution should be observed with the use of all dental materials.
• It has also been recommended by certain regulatory authorities that consideration be given to the use
• It has also been recommended by certain regulatory authorities that consideration be given to the use
• It has also been recommended by certain regulatory authorities that consideration be given to the use
• It has also been recommended by certain regulatory authorities that consideration be given to the use
• It has also been recommended by certain regulatory authorities that consideration be given to the use
• It has also been recommended by certain regulatory authorities that consideration be given to the use
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
of amalgam fillings in children and that amalgams not be used in patients with severe renal disease.
2. Health Canada Warnings:
2. Health Canada Warnings:
2. Health Canada Warnings:
2. Health Canada Warnings:
2. Health Canada Warnings:
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of children
• Non-mercury filling materials should be considered for restoring the primary teeth of children
• Non-mercury filling materials should be considered for restoring the primary teeth of children
• Non-mercury filling materials should be considered for restoring the primary teeth of children
• Non-mercury filling materials should be considered for restoring the primary teeth of children
• Non-mercury filling materials should be considered for restoring the primary teeth of children
where the mechanical properties of the material are suitable.
where the mechanical properties of the material are suitable.
where the mechanical properties of the material are suitable.
where the mechanical properties of the material are suitable.
where the mechanical properties of the material are suitable.
where the mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
pregnant women.
pregnant women.
pregnant women.
pregnant women.
pregnant women.
pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• Amalgam should not be placed in patients with impaired kidney function.
• Amalgam should not be placed in patients with impaired kidney function.
• Amalgam should not be placed in patients with impaired kidney function.
• Amalgam should not be placed in patients with impaired kidney function.
• Amalgam should not be placed in patients with impaired kidney function.
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
• In placing and removing amalgam fillings, dentists should use techniques and equipment to
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
minimize the exposure of the patient and the dentist to mercury vapor and to prevent amalgam
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
waste from being flushed into municipal sewage systems.
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
• Dentists should advise individuals who may have allergic hypersensitivity to mercury to avoid the
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
use of amalgam. In patients who have developed hypersensitivity to amalgam, existing amalgam
1 spill 1 spill 2 spill 2 spill
1 spill 2 spill
1 spill 2 spill
1 spill 2 spill
1 spill 2 spill
217 mg 326 mg
217 mg 326 mg
217 mg 326 mg
217 mg 326 mg
217 mg 326 mg
217 mg 326 mg
110 mg 164 mg
110 mg 164 mg
110 mg 164 mg
110 mg 164 mg
110 mg 164 mg
110 mg 164 mg
56 mg 85 mg
56 mg 85 mg
56 mg 85 mg
56 mg 85 mg
56 mg 85 mg
56 mg 85 mg
295 mg 437 mg
295 mg 437 mg
295 mg 437 mg
295 mg 437 mg
295 mg 437 mg
295 mg 437 mg
EZ
®
3 spill 3 spill Weight % Weight %
3 spill Weight %
3 spill Weight %
3 spill Weight %
3 spill Weight %
435 mg 56.7%
435 mg 56.7%
435 mg 56.7%
435 mg 56.7%
435 mg 56.7%
435 mg 56.7%
219 mg 28.6%
219 mg 28.6%
219 mg 28.6%
219 mg 28.6%
219 mg 28.6%
219 mg 28.6%
113 mg 14.7%
113 mg 14.7%
113 mg 14.7%
113 mg 14.7%
113 mg 14.7%
113 mg 14.7%
593 mg
593 mg
593 mg
593 mg
593 mg
593 mg
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