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"DIRECTIONS FOR USE

Dispersalloy®

Tablets and Powder

A dispensed phase admix amalgam, containing lathe-cut particles and silver/copper eutectic spheres. Caution: U.S. Federal law restricts this device to sale by or on the order of a dentist. For dental use only.

Composition

		Powder (for 100g.)		Tablets
Silver		69.5 g		.270 g
Tin		17.7 g		.069 g
Copper		11.8 g		.046 g
Zinc		1.0 g		.004 g

Indication for use

Dispersalloy® should be used in stress bearing restorations (Class 1 and 2), when other restorative materials or restoration techniques are not indicated.

Contraindication

The use of amalgam is contraindicated;

• In proximal or occlusal contact to dissimilar metal restorations.
• In patients with severe renal deficiency.
• In patients with known allergies to amalgam.
• For retrograde or endodontic filling.
• As a filling material for cast crown.
• In children 6 and under.
• In expectant mothers.

Side Effects/Warning

Prior to use, read the MSDS information and product instructions for this item.

Exposure to mercury may cause irritation to skin, eyes, respiratory tract and mucous membrane. In individual cases, hypersensitivity reactions, allergies, or electrochemically caused local reactions have been observed. Due to electrochemical processes, the lichen planus of the mucosa may develop.

Mercury may also be a skin sensitizer, pulmonary sensitizer, nephrotoxin and neurotoxin.

After placement or removal of amalgam restorations, there is a temporary increase of the mercury concentration in the blood and urine.

Mercury expressed during condensation and unset amalgam may cause amalgamation or galvanic effect if in contact with other metal restorations. If symptoms persist, the amalgam should be replaced by a different material.

Removal of clinically acceptable amalgam restorations should be avoided to minimize mercury exposure, especially in expectant mothers.

Precautions

The number of amalgam restorations for one patient should be kept to a minimum.

Inhalation of mercury vapor by dental staff may be avoided by proper handling of the amalgam, the use of masks, along with adequate ventilation.

Avoid contact with skin and wear safety glasses and gloves.

Store amalgam scrap in well sealed containers. Regulations for disposal must be observed.
DISPERSALLOY® CONTAINS ZINC; THE AMALGAM MADE THEREFROM MAY SHOW EXCESSIVE EXPANSION IF MOISTURE IS INTRODUCED DURING MIXING, CONDENSING AND COMPACTING.

Proportions

As with all alloys, the ratio mercury to alloy is important. A 1:1 mercury/alloy ratio is recommended. When using either Dispersalloy ® Tablets or Powder, we recommend using an automatic powder and mercury proportioner. It will automatically and precisely dispense measured amounts of mercury and alloy. Refer to the instructions provided by the proportioner manufacturer.

Step-By-Step Instructions

1. Trituration

Trituration speed and time are important factors in the handling properties of any amalgam. Use Caulk reusable capsule and pestle for best results. The chart that follows provides guidelines in determining amalgamator trituration time and speed setting for Dispersalloy ® Powder and Tablets:

2. Condensation

Mercury need not be removed from the triturated amalgam prior to condensing. Condense immediately after mix is completed. Pack angles and undercuts with small-faced plugger and sufficient pressure to insure good adaptation. Build the restoration with additional portions, until the cavity is slightly overfilled. Remove any mercury-rich amalgam from the surface that may develop during condensation.

3. Carving / Burnishing

Carving can begin immediately after condensation. A sharp carver will give best results. Burnishing setting amalgam is recommended to improve surface smoothness.

4. Polishing

The quality of the Dispersalloy® restoration will be enhanced by polishing. The amalgam should be allowed to set 24 to 48 hours before polishing.

Suggestions for best results with Dispersalloy®

• Manufacturer's variation in amalgamators and differences in local electrical current may necessitate adjusting trituration time. The amalgam should be a coherent plastic mass that may feel slightly warm. Overtrituration may result in a dry mix which feels hot. If this occurs decrease trituration time. Undertrituration may result in a wet, or crumbly mix. If this occurs, increase trituration time.
• Properly triturated Dispersalloy® does not require mulling to produce a smooth plasticity; however you may mull for 1-2 seconds after removing pestle to collect amalgam into a single mass.
• Before the matrix band is removed, the marginal ridge should be carved with an explorer.
• When the matrix band is removed, the marginal ridge should be supported.
• After removal of the matrix band, gingival margins may be smoothed with a curved explorer.
• The anatomy should be carved proceeding from the proximal margins towards the center of the restoration.

Storage
Do not store under extreme conditions of temperature and humidity.

LOT number and Expiry date

• Do not use after expiry date.
• The lot number indicates important production information. The number should be quoted in all correspondence which requires identification of the product.

Made by:
DENTSPLY Caulk
DENTSPLY INTERNATIONAL INC.
Milford, DE 19963-0359
U.S.A.
1-800-532-2855
Responsible distributor in Europe:
DENTSPLY DeTrey Gmbh
De-Trey-Strasse 1
D-78467 Konstanz
Germany

556011 (R-9/97) "

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