maquira Bond 2.1 4mL Bottle Instruction Manual

maquira Bond 2.1 4mL Bottle Instruction Manual

DESCRIPTION:

The Bond 2.1 product incorporates the two components, primer and bonding agent, in a single bottle, simplifying clinical procedures, with excellent results in terms of bond strengths.
However, these easy-to-use and quick-to-apply systems require acid etching and multiple adhesive applications to achieve maximum adhesion to enamel and dentin.

PRESENTATIONS:

Bottle with 4 ml, 5 ml or 6 ml.

INDICATIONS OF USE:

Bond 2.1 is indicated for:

• Direct restorations of light-curing resins.
• Indirect restorations: inlay, only and laminates.
• Restorations with intra-radicular retainer (when used together with a resin cement).
• Prosthetic restorations: single crowns and fixed prostheses with more elements.

COMPOSITION:

Methacrylic monomers, photo initiator, ethanol, inert fillers.

MODE OF USE:

Dosage packaging:

1. Shake before use.
2. Drip one or two drops (depending on the size of the restoration) of Bond 2.1 onto a glass plate.
3. Immediately close the dispenser cap.

Conventional technique (with acid etching):

1. Perform prophylaxis of the area to be worked on.

2. Apply anaesthesia, when necessary.

3. Properly isolate the area according to the clinical case. In some cases, absolute isolation should be performed. In cases where pulp protection is required, use calcium hydroxide-based lining materials.

4. Apply 37% phosphoric acid in the region to be worked (enamel and dentin): for dentin region the conditioning should be 15 seconds, for enamel the contact should be 30 seconds. To remove the conditioning agent, apply plenty of water for 30
   seconds and 60 seconds for dentin and enamel, respectively.

5. Excess water should be removed with gauze or air jet.

6. Enamel should be dried completely, but dentin should be kept slightly moist.

7. Apply Bond 2.1 to enamel or dentin.

8. Use micro-applicators in the form of a brush, making gentle movements over the surface to be worked. The application time should be longer than 1 0 seconds.

9. Ensure coverage of the area.

10. Apply a gentle blast of air to the area to evaporate solvents.

11. Photoactivate the region covered with Bond 2.1 for 20 seconds in position. A polymerize with a power higher than 1200 mW/cm2 should be used.

12. After polymerization, the product should have a shiny surface. If this is not observed, the product should be reapplied.

13. Photoactivation should be conducted point by point.

14. Insert the restorative material according to the manufacturer1s directions for use.

Repair of ceramic or composite resin restorations:

1. Clean the area to be worked on.

2. Bevel the restoration margins.

3. Perform acid etching with 37% phosphoric acid.

4. Rinse with plenty of water.

5. Apply Bond 2.1 on the surface to be repaired, using a brush-like micro-applicator.

6. Ensure a thin layer of material forms on the surface.

7. Make gentle movements and wait 1 minute.
   Apply the air jet for 5 seconds. Photoactivate the area covered with Bond 2.1 for 20 seconds in position. A polymerize with a power higher than 1200 mW/cm2 should be used.

8. Perform the repair with composite resin, according to the manufacturer1s instructions for use.

Core filling using light-curing/dual-curing composites:

1. Apply Bond 2.1 to the tooth structure to receive the crown according to the self-curing technique.
2. Place a light-curing resin-based composite or a dual-curing resin-based composite according to the manufacturer1s instructions for use.
3. Polymerize the Bond 2.1 application region with blue light and start the crown preparation process.

WARNINGS:

• Exclusive use of the dental surgeon.
• Do not use the product after its expiration date.
• Do not reuse the empty packaging.
• Keep the material out of the reach of children.
• This material has been manufactured for dental use only and must be handled in accordance with the instructions for use. The manufacturer is not responsible for damage caused by other uses or by incorrect handling not described in this manual. In addition, the user is obliged to check, before use and under his own responsibility, whether this material is compatible with the intended use, especially when this use is not indicated in this indication for use.
• Bond 2.1 should not be swallowed, aspirated or inhaled. Ingestion may cause gastric irritation. Inhalation may cause allergy in the respiratory tract. In case of ingestion, aspiration or inhalation, seek medical attention immediately.
• Bond 2.1 contains ethanol, a flammable substance, do not handle near heat sources.
• Avoid prolonged contact of acids, adhesive agents and composite with the skin or oral soft tissue as it may cause tissue inflammation or skin sensitization.
• Bond 2.1 may cause moderate irritation in contact with eyes and skin. In case of contact, remove the material immediately and wash thoroughly with soap and water.
• Ideally, a light-curing device with a power higher than 1200 mW/cm2 should be used. At lower powers, in some cases, the product should be photoactivated for 40 seconds.
• Do not use the product directly on the dental pulp.
• In case of contact, remove the material immediately and wash thoroughly with soap and water.
• At high temperatures, the product may lose its efficiency and usability. To avoid these situations, the product should be stored at a controlled temperature below 25 °C, without exposure to direct light.
• Do not handle the Bond 2.1 bottle with the light of the reflector directly focused on the opened package.
• Do not project the light from the light curing device directly onto the opened bottle.

PRECAUTIONS:

• Do not apply Bond 2.1 adhesive to areas where repair is not desired, as adhesion to the surface may occur, making it difficult to remove excess and clean the restoration.
• Wear PPE when handling the product, including gloves and goggles. It is recommended that patients also wear goggles.
• Do not allow loose polymerized objects and parts to be swallowed or aspirated.
• If the product comes into contact with hands, wash with plenty of water.
• In case of allergic reactions discontinue use immediately. If necessary seek medical advice.
• Product for single use only. After polymerization the product does not return to its initial consistency.
• Reprocessing is prohibited.
• Do not expose the material to temperatures above 25°C.
• Do not expose the material directly to sunlight.
• Replace the cap on the bottle immediately after use.

CONTRAINDICATIONS:

• Do not use this material in patients allergic or hypersensitive to any component of the formula.
• The product may cause some level of irritation if in contact with the dental pulp and/or very close to it.
• Avoid contact of the unpolymerized composite with skin, mucosa and eyes. When not yet polymerized, the product may cause a mild irritant effect and promote sensitization due to methacrylate’s.
• Avoid the use of eugenol-based lining or provisional materials as they interfere with the  polymerization of the product.

ADVERSE EFFECT:

No adverse effects of the product have been identified to date.

STORAGE CONDITIONS:

• Store the product in its original packaging and in a clean, dry place.
• Store Bond 2.1 adhesive properly sealed and without exposure to light or high humidity.
• The product should be kept at a controlled temperature between 4 °C – 25 °C.

TRANSPORTATION CONDITIONS:

For transportation, the product should be kept at a temperature below 40 °C for a maximum of 15 days.

VALIDITY:

If properly packaged, the product has a shelf life of 24 months from the date of manufacture.
Do not use after the expiration date.

DISPOSAL:

Do not reuse the product and dispose of in accordance with local legislation.

Symbology

MADE IN BRAZIL Fabricante I Manufacturer:
Maquira lndustria de Produtos
Odontol6gicos S.A.
CNPJ: 05.B23.205/0001-90
Endere~o I Direccion I Address:
Av. Melvin Jones, 773
Pq. Ind. Bandeirantes
Maringa – PR I 87070-030 I Brasil
Resp. Tecnico I Technical Resp.:
Cristiane Furlan I CRF-PR: 14.03B
Reg. ANVISA N°: 80322400085

SAP:
Atendimento ao cliente
Atenci6n al cliente
Customer service
0B00 726 SB4B
sap@maquira.com.br

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