DENTSPLY Megalloy EZ Instrucciones De Uso

Megalloy
Spherical Alloy Self-Activating Capsule
DIRECTIONS FOR USE – ENGLISH
For dental use only.
USA: Rx only.
Megalloy ® EZ Spherical Alloy is a high strength, high copper, spherical alloy.
1. COMPOSITION
Alloy Powder 1 spill 2 spill
Silver 217 mg 326 mg
Tin 110 mg 164 mg
Copper 56 mg 85 mg
Mercury 295 mg 437 mg
The recommended alloy to mercury ratio by mass is approximately 1.3:1.
2. INDICATION FOR USE
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.
3. CONTRAINDICATION
The use of amalgam is contraindicated in patients with known allergies to amalgams or any of
the components.
Safety alert symbol
This is the safety alert symbol. It is used to alert you to potential personal injury
hazards. Obey all safety messages that follow this symbol to avoid possible injury.
4. WARNINGS
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 dental amalgams:
• After placement or removal of dental amalgam restorations increased mercury
concentration in blood and urine has been observed. According to available scientific
knowledge this 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 they will be of short lasting duration. If the effect persists the user should consider
replacement of the dental amalgam filling with another material.
• 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 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.
• 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.
2. Health Canada Warnings:
• Non-mercury filling materials should be considered for restoring the primary teeth of
children where the mechanical properties of the material are suitable.
• Whenever possible, amalgam fillings should not be placed in or removed from the teeth of
pregnant women.
• Amalgam should not be placed in patients with impaired kidney function.
• 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 waste from being flushed into municipal sewage systems.
• 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 restorations should be replaced with another material where this is
recommended by a physician.
3. Alloy amalgam capsule products contain mercury, which can cause skin sensitization or other
allergic reaction. Although the mercury in this product is bound within the amalgam following
trituration, proper care should be taken to prevent exposure to mercury.
Skin Contact: Before using this product wear protective safety glasses, clothing and gloves.
If contact with skin occurs immediately wipe off and flush with generous amounts of water,
then wash well with soap and water after contact. If skin rash, irritation, sensitization or other
allergic reaction occurs, discontinue use and seek medical attention immediately.
Eye Contact: May be irritating to eyes. Before using this product wear protective glasses as
well as covering the patient's eyes to protect from excess. The use of an enclosed
amalgamator is recommended. In case of accidental contact with eyes, rinse eyes
immediately with plenty of water and seek medical attention.
Ingestion: Do not swallow or take internally. Whenever possible, the use of protective barriers
such as rubber dam isolation and protective mask during placement and removal is
recommended. If accidental swallowing occurs, drink lots of water. If nausea or illness
develop, seek medical attention immediately. Contact regional Poison Control Center
immediately.
Inhalation: Do not breathe vapor. Whenever possible, the use of protective barriers such as
rubber dam isolation, high-volume evacuation and protective mask during placement and
removal is recommended. Give oxygen or artificial respiration if necessary.
EZ
®
3 spill Weight %
435 mg 56.7%
219 mg 28.6%
113 mg 14.7%
593 mg
4. Do not open capsule prior to trituration. Do not remove or handle mixing pestle or
plastic wafer containing mercury.
5. Do not attempt to clean and/or reuse capsules.
5. PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions for Use.
Any use of this product inconsistent with the Directions for Use is at the discretion and sole
responsibility of the practitioner.
2. Wear suitable protective eyewear, clothing, mask and gloves. Protective eyewear, and
whenever possible, barrier techniques such as rubber dam is recommended for patients. (See
Warnings)
3. Devices marked "single use" on the labeling are intended for single use only. Discard after
use. Do not reuse.
4. Mercury corrodes and embrittles particular metals and their alloys. Avoid unnecessary
contact between mercury and metals.
5. Mercury presents a health hazard if incorrectly handled. Mercury is toxic by vapor inhalation
and the effect is cumulative. Spillages of mercury should be removed immediately, including
places which are difficult to access. Use a plastic syringe to draw it up. Smaller quantities
can be covered by sulfur powder and removed. Avoid inhalation of the vapor.
6. Regulations for disposal must be observed. Adherence to the American Dental Association's
current "Best Management Practices For Amalgam Waste (BMPs)" and "Dental Mercury
Hygiene Recommendations" is strongly recommended. Among these practices:
• Salvage and store non-contact amalgam scrap in well-sealed containers and recycle.
• Salvage and store contact amalgam pieces from restorations, traps and filters in well-
sealed containers and recycle.
• Do not dispose of amalgam scrap, waste or extracted teeth in regulated infectious waste
containers that will be incinerated, or in regular garbage.
• Recycle used disposable amalgam capsules and plastic wafer (which contained mercury
before mixing).
7. Waste material and all primary containers that hold mercury must be disposed of as
hazardous waste.
8. If moisture is introduced into the amalgam before it has set, properties such as strength and
corrosion resistance may be affected adversely. If the alloy contains zinc, such contamination
may result in an excessive expansion (delayed expansion). Whenever it is possible, use a dry
field.
9. Manufacturer's variation in amalgamators and differences in local electrical current may
necessitate adjusting trituration time to obtain an optimal mix.
10. Insufficient data exist to support the use of amalgamators not listed in the chart below. Use
of amalgamators other than those listed may result in less than optimally triturated
amalgam. The operator must investigate non-listed equipment compatibility and/or consult
amalgamator manufacturer for recommendations.
11. Do not attempt to place improperly triturated amalgam, or amalgam that has exceeded
working time (dry, crumbly).
12. Drilling, polishing and grinding dental fillings should always be combined with water-cooling
and suction under a vacuum.
13. The following precautions are required by the General Director AFSSAPS (Agence française
de sécuité sanitaire des produits de santé – French agency for Sanitary Security of Health
Products):
• Store amalgam capsules in a cool and ventilated space.
• Work in ventilated rooms with decontaminable non-textile surfaces.
• Realize shaping and polishing of amalgam always under cooling and suction of the
operation field.
• Condense amalgam with classical methods (plugger) and do not use ultrasound
condensers.
• Do not place amalgam in direct proximity of other metallic restorations in order to avoid all
risk of corrosion.
• Avoid placing and removing amalgam during pregnancy and lactation.
• If local reactions, in particular lichoid lesions in the proximity of amalgam, occur, it is
justified to remove the filling.
6. STORAGE
Megalloy ® EZ Amalgam in Self-Activating Capsules should be stored in a well ventilated place at
temperature not to exceed 25ºC/77ºF. Do not allow exposure to moisture or excessive humidity.
Do not use after expiration date.
7. ADVERSE REACTIONS
1. Product may irritate skin, eyes. Skin contact: irritation or possible allergic response. Reddish
rashes may be seen on the skin. Eye contact: irritation and possible corneal damage. (See
Warnings and Precautions)
2. Inhalation of vapors may cause varying degrees of damage to the affected tissue and also
increased susceptibility to respiratory illness. (See Warnings and Precautions)
3. Product may cause neurotoxic, nephrotoxic or other serious health effects if inhaled or
ingested. (See Warnings)