GC AMERICA GCA-009277 G-Premio Bond One Component Light-Cured Adhesive Refill Kit Instruction Manual

GC AMERICA GCA-009277 G-Premio Bond One Component Light-Cured Adhesive

Refill Kit

For use only by a dental professional in the recommended indications.

RECOMMENDED INDICATIONS

1. Direct bonding of light-cured composites and compomers to tooth structure
2. Bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured.
3. Intraoral repair of composite, metal-based and zirconia/alumina-based restorations
4. Intraoral repair of ceramic restorations in combination with a silane coupling agent
5. Treatment of hypersensitive teeth
6. Sealing of tooth preparation (cavity or abutment) for indirect restorations

CONTRAINDICATION

1. Direct pulp capping.
2. Avoid use of this product in patients with known allergies to methacrylate monomer, methacrylate polymer, or acetone.

NOT TO BE USED

1. In combination with chemically cured composite resin.
2. In combination with eugenol containing materials as eugenol may hinder G-Premio BOND from setting or bonding properly.
3. In combination with desensitizers as desensitizers may hinder G- Premio BOND from setting or bonding properly.

DIRECTIONS FOR USE

1. BONDING PROCEDURE

   • CAVITY PREPARATION
     Prepare tooth using standard techniques. Make sure that the temporary material is thoroughly removed from the surface. Use rubber dam for protection. Rinse and dry the prepared tooth surfaces by gently blowing with an air syringe.
     Note:
     For pulp capping, use calcium hydroxide.

2. TREATMENT OF TOOTH SURFACES
   Select out of the following 3 technique options:

   • Self-etch technique
     Apply G-Premio BOND to bur-cut enamel and dentin, without a separate etching step.
     Note:
     Non bur-cut enamel should always be treated with a 35- 40% phosphoric acid gel for 10 seconds, rinsed with water for 5 seconds and gently dried.

   •  Selective etching of enamel Prior to applying G-Premio BOND to enamel and dentin, etch enamel only with 35-40% phosphoric acid gel for 10-15 seconds, rinse for 5 seconds and gently dry.

   • Total-etch technique
     Prior to applying G-Premio BOND to enamel and dentin, etch enamel and dentin with 35-40% phosphoric acid gel for 10-15 seconds, rinse for 5 seconds and gently dry.

3. APPLICATION OF G-Premio BOND

   • Bottle type: Prior to dispensing, shake the bottle of G- Premio BOND thoroughly. To open the flip-top cap, pinch both cap release buttons on the neck of the bottle at the same time, as illustrated in Figure 1. Dispense a few drops into a clean dispensing dish. Close the cap immediately.
     Note:

   • If the cap detaches from the bottle, it may be reattached by reseating the cap on the hinge pegs, as shown in Figure 2.

   • Wipe any excess liquid from the nozzle before closing the cap. Unit dose type: Before opening unit dose capsule, ensure top of the capsule is facing up. Unscrew cap counterclockwise. Using the disposable applicator provided, mix the liquid thoroughly for 5 seconds, making sure to agitate material from the bottom and sides of the capsule.
     Note:
     If the cap of the unit dose is too tight to open, use another unit dose. Do not try to open the unit dose capsule with excessive force as this may cause the liquid inside to spill and cause accidental contact with skin and eyes.

   • IMMEDIATELY apply to the prepared enamel and dentin surfaces using the disposable applicator.

   • Leave undisturbed for 10 seconds after the end of application. G-Premio BOND can provide sufficient bonding strength even when dried immediately after application without waiting time.

   • Dry thoroughly for 5 seconds with oil free air under MAXIMUM air pressure. Use vacuum suction to prevent splatter of the adhesive. The final result should be a thin adhesive film with a glossy surface and which does not visibly move under further air pressure. Notes:

   • When removing from refrigerator after long-term storage, allow G-Premio BOND to stand at room temperature for several minutes prior to use.

   • Apply G-Premio BOND immediately as the material contains a volatile solvent.

   • G-Premio BOND is a light-cured material. Protect the liquid from light after dispensing.

   • Remove excess material remaining on the tooth (other than the surfaces to be bonded) using a sponge or cotton pellet as residue material is hard to remove after light curing.

   •  Should the applied material be contaminated with water, blood or saliva prior to light curing, wash and dry the tooth and repeat the procedure by re-applying material.

4. LIGHT CURING
   Light cure using a visible light curing unit. Irradiation time

5. PLACEMENT OF LIGHT-CURED COMPOSITES AND COMPOMERS
   After having light-cured the adhesive, follow manufacturer’s instructions for use in order to place, contour and light-cure the composite resin material of choice.

   • PLACEMENT OF DUAL-CURED COMPOSITES
     After having light-cured the adhesive, make sure to light-cure the dual-cured composite material separately. Self-curing only will result in insufficient bonding strength.

6. FINISHING
   Adjust restoration, finish and polish using standard techniques.

REPAIR SITUATIONS

1. PREPARATION OF RESTORATION
   Roughen the adherent surfaces using a diamond point.Use rubber dam for protection. Rinse and dry the prepared surfaces by blowing with an air syringe. If the restoration surface contains glass ceramics or hybrid ceramics treat those surfaces using a silane coupling agent such as CERAMIC PRIMER II prior to application of G-Premio BOND.
   Note:
   Do NOT apply CERAMIC PRIMER II to metal and/or tooth surface.

2. TREATMENT OF TOOTH SURFACES
   Select out of the following 3 technique options:

   • Self-etch technique
     Apply G-Premio BOND to bur-cut enamel and dentin, without a separate etching step.
     Note:
     Non bur-cut enamel should always be treated with a 35- 40% phosphoric acid gel for 10 seconds, rinsed with water for 5 seconds and gently dried.

   • Selective etching of enamel
     Prior to applying G-Premio BOND to enamel and dentin, etch enamel only with 35-40% phosphoric acid gel for 10-15 seconds, rinse for 5 seconds and gently dry.

   • Total-etch technique
     Prior to applying G-Premio BOND to enamel and dentin, etch enamel and dentin with 35-40% phosphoric acid gel for 10-15 seconds, rinse for 5 seconds and gently dry.

3. APPLICATION OF G-Premio BOND

   • Bottle type: Prior to dispensing, shake the bottle of G- Premio BOND thoroughly. Dispense a few drops into
     a clean dispensing dish. Replace bottle cap immediately.

   • Unit dose type: Unscrew cap of unit dose counterclockwise. Make sure to identify the top and bottom of the unit dose capsule before opening. Using the disposable applicator provided, mix the liquid thoroughly for 5 seconds, making sure to combine liquid from top and bottom of the container.

   •  IMMEDIATELY apply to all repaired surfaces using the disposable applicator.

   • Leave undisturbed for 10 seconds after the end of application. G-Premio BOND can provide sufficient bonding strength even when dried immediately after application without waiting time.

   • Dry thoroughly for 5 seconds with oil free air under MAXIMUM air pressure. Use vacuum suction to prevent splatter of the adhesive. The final result should be a thin adhesive film with a glossy surface and which does not visibly move under further air pressure.
     Notes:

   • When removing from refrigerator after long-term storage, allow G-Premio BOND to stand at room temperature for several minutes prior to use.

   •  If the cap of the unit dose is too tight to open, to avoid accidental contact of the liquid with skin and eyes, do not try to open it with force. Use another unit dose.

   • Apply G-Premio BOND immediately as the material contains a volatile solvent.

   •  G-Premio BOND is a light-cured material. Protect the liquid from light after dispensing from the bottle.

   • Remove excess material remaining on the tooth (other than the surfaces to be bonded) using a sponge or cotton pellet as residue material is hard to remove after light curing.

   • Should the applied material be contaminated with water, blood or saliva prior to light curing, wash and dry the tooth and repeat the procedure by re-applying material.

4. LIGHT CURING
   Light cure using a visible light curing unit. Refer to I. BONDING PROCEDURE,

5. LIGHT-CURING

6. PLACEMENT OF LIGHT-CURED COMPOSITES/COMPOMERS
   After having light-cured the adhesive, follow manufacturer’s instructions for use in order to place, contour and light-cure the composite resin material of choice.

7. FINISHING
   Adjust restoration, finish and polish using standard techniques.

TREATMENT OF HYPERSENSITIVE TEETH AND IMMEDIATE DENTIN SEALING

1. APPLICATION OF G-Premio BOND
   Refer to I. BONDING PROCEDURE, 2. TREATMENT OF TOOTH SURFACES and 3. APPLICATION OF G-Premio BOND. Wait 10 seconds before drying.
   Note:
   For the treatment of hypersensitive teeth, the self-etch technique is recommended.

2. LIGHT CURING
   Refer to I. BONDING PROCEDURE, 4. LIGHT-CURING

3. REMOVE UNPOLYMERIZED LAYER
   Remove the unpolymerized layer of G-Premio BOND using a moist cotton pellet.

STORAGE
Store at room temperature (1-25°C) (33.8-77.0°F). If not in use for a prolonged period of time, store in refrigerator.

PACKAGE

• G-Premio BOND Bottle Kit: 5 mL liquid (1), disposable dispensing dish (20), DISPOSABLE APPLICATOR II (50)
• G-Premio BOND Bottle Refill: 5 mL liquid (1)
• G-Premio BOND 3-Bottle Pack: 5 mL liquid (3)
• G-Premio BOND Unit Dose: 0.1 mL liquid (50), DISPOSABLE APPLICATOR II (50)

CAUTION

1. In rare cases, the product may cause sensitivity in some people. If such reaction occurs, discontinue the use of the product and refer to a physician.

2. Personal protective equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.

3. Avoid inhalation or ingestion of material.

4. G-Premio BOND is a highly flammable liquid and vapour. Do not use near open flame. Keep away from sources of ignition. Do not store large quantities in one area. Keep away from direct sunlight.

5. G-Premio BOND is volatile. Use in a well-ventilated place. Advise patients to breathe through nose.

6. G-Premio Bond unit dose is for single use only. Do not attempt to recap or reuse. Unit Dose cannot be recapped properly once
   opened and the volatile solvent may evaporate.

7. In case of contact with eyes, flush immediately with water and seek medical attention.

8. In case of contact with oral tissue or skin, immediately remove with a sponge or cotton pellet. After the restorative treatment is
   finished, rinse thoroughly with water.

9. If the tissue contacted by the material turns white or forms a blister, advise the patient to leave the affected area undisturbed,
   until the mark disappears, usually in 1-2 weeks. To avoid contact, it is recommended to apply COCOA BUTTER to areas which cannot be covered with a rubber dam.

10. In case of surface spills, immediately wipe off with a dry cloth.

11. Do not mix with other products.

12. Dispose of contents/container in accordance with local regulations.

Some products referenced in the present IFU may be classified as hazardous according to GHS. Always familiarize yourself with the
safety data sheets available at:
http://www.gceurope.com or for The Americas http://www.gcamerica.com They can also be obtained from your supplier.

CLEANING AND DISINFECTING:
MULTI-USE DELIVERY SYSTEMS: to avoid cross-contamination between patients this device requires mid-level disinfection. Immediately after use inspect device and label for deterioration. Discard device if damaged.

DO NOT IMMERSE.
Thoroughly clean device to prevent drying and accumulation of contaminants. Disinfect with a mid-level registered healthcare-grade infection control product according to regional /national guidelines.

Undesired effects- Reporting:
If you become aware of any kind of undesired effect, reaction or similar events experienced by use of this product, including those
not listed in this instruction for use, please report them directly through the relevant vigilance system, by selecting the proper
authority of your country accessible through the following link: https://ec.europa.eu/growth/sectors/medical-devices/contacts_en
as well as to our internal vigilance system: [email protected] In this way you will contribute to improve the safety of this product.

MANUFACTURED by

• GC DENTAL PRODUCTS CORP.
  2-285 Toriimatsu-cho, Kasugai, Aichi 486-0844, Japan
  RESPONSIBLE MANUFACTURER IN CANADA:

• GC AMERICA INC.
  3737 West 127th Street, Alsip, IL 60803 U.S.A.
  DISTRIBUTED by

• GC CORPORATION
  76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japan

• : GC EUROPE N.V.
  Researchpark Haasrode-Leuven 1240, Interleuvenlaan 33,
  B-3001 Leuven, Belgium TEL: +32 16 74 10 00

• GC AMERICA INC.
  3737 West 127th Street, Alsip, IL 60803 U.S.A.
  TEL: +1-708-597-0900
  www.gcamerica.com

• GC SOUTH AMERICA
  Rua Heliodora, 399, Santana – São Paulo, SP, BRASIL
  CEP: 02022-051 – TEL: +55-11-2925-0965
  CNPJ: 08.279.999/0001-61
  RESP. TÉC: Erick de Lima – CRO/SP 100.866

• GC ASIA DENTAL PTE. LTD.
  5 Tampines Central 1, #06-01 Tampines Plaza 2, Singapore 529541
  TEL: +65 6546 7588

• GC AUSTRALASIA DENTAL PTY. LTD.
  1753 Botany Rd, Banksmeadow, NSW 2019, Australia
  TEL: +61 2 9301 8200
  PRINTED IN JAPAN

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