GC Fuji Ortho LC 50 Capsule for Orthodontic Instructions

GC Fuji Ortho LC 50 Capsule for Orthodontic

GC Fuji ORTHO™ LC CAPSULE

LIGHT-CURED ORTHODONTIC BONDING ADHESIVE IN CAPSULES For use only by a dental professional in the recommended indications.

RECOMMENDED INDICATIONS

1. Bonding metal brackets and attachments.
2. Bonding ceramic brackets.
3. Bonding acrylic appliances.
4. Band cementation only when extra band retention is desired.

CONTRAINDICATIONS

1. Avoid use of this product in patients with known allergies to glass ionomer cement, methacrylate monomer or methacrylate polymer.
2. Bonding polycarbonate brackets.
3. Cementation of stainless steel crown-retained appliances (e.g., Herbst Appliances).

DIRECTIONS FOR USE

1. ENAMEL PREPARATION

   • Using a prophy cup or a brush, clean the bonding surfaces of the teeth with plain (non-fluoridated) pumice and water.

   • Rinse thoroughly with water.

   • Using a sponge or a cotton pellet, apply ORTHO CONDITIONER to the bonding surfaces of the teeth for 20 seconds. Rinse thoroughly.
     Although successful results have been obtained with no enamel pretreatment, conditioning of the enamel bonding surfaces will increase the adhesive’s bond strength. It is therefore recommended, especially for new users of GC Fuji ORTHO LC.

   • Optional: Etch the enamel bonding surfaces according to the etchant manufacturer’s instructions. Rinse thoroughly.

   • Note: The enamel bonding surfaces must be moist. An overly dry or desiccated enamel surface will adversely affect the bond strength. The optimum level of surface moisture can be obtained by wiping the bonding surfaces of the teeth with a moistened cotton roll immediately prior to bracket bonding.

   • If the bonding surfaces become desiccated during the bonding procedure, rehydrate by wiping them with the moistened cotton roll before bonding with GC Fuji ORTHO LC.

2. CAPSULE ACTIVATION AND MIXING

   • Before activation, shake the capsule or tap its side on a hard surface to loosen the powder (Fig. 1).
   • To activate the capsule, push the plunger until it is fully depressed with the main body and hold it down for 2 seconds (Fig. 2).
   • Ensure the plunger is fully pressed to avoid the incorrect mixing ratio of powder and liquid.
   • The capsule should be activated just before mixing and used immediately.
   • Immediately set it into a mixer (or anamalgamator) and mix for 10 seconds (+/-4,000 RPM) (Fig. 3). The working time is approximately 3 minutes from start of mix at 23°C (73°F). Higher temperatures will Fig. 3 shorten working time and lower temperatures will extend it. Refrigeration of capsules is therefore recommended until immediately prior to activation and use.
   • Note: Fig. 4 The capsule should be activated just prior to mixing. After mixing, immediately extrude the adhesive onto the bonding surface of the bracket or appliance.

3. EXTRUDING THE ADHESIVE

   • Immediately remove the mixed capsule from the mixer and load it into the GC CAPSULE APPLIER.

   • Extrude the material by pulling the lever 4 or 5 times Coat the bonding surface of the bracket or appliance completely with adhesive.
     Note:   To adjust the direction of the nozzle, hold the applier with the capsule towards you and turn the capsule body.

   • To remove the used capsule, push the applier release button. Twist the capsule and pull upwards.

   • GC Fuji ORTHO LC CAPSULE may not function properly in a non-GC-manufactured capsule applier. If a different capsule applier is to be used, check and confirm compatibility prior to use.

4. BONDING PROCEDURE

   • Coat the bonding surface of the bracket completely with the mixed adhesive.
   • Position the coated bracket on the tooth.
   • Press the bracket firmly against the enamel surface. Using an explorer or a scaler, remove the excess adhesive at this time. Press the bracket again. Continue placing additional brackets. Place all brackets in a quadrant or in the full arch. More than one mix of adhesive may be necessary. If bracket drift is a concern, “tack” the brackets by light curing for approximately 5 seconds.
   • AFTER REMOVING EXCESS ADHESIVE, BE CAREFUL NOT TO DISTURB THE BRACKETS BEFORE THE ADHESIVE IS CURED. THE MOVEMENT OF THE BRACKETS AT THIS POINT MIGHT DECREASE THE BOND STRENGTH.
   • Using a curing light (470 nm wavelength), cure each bracket for 10 seconds each of the occlusal, mesial, distal, and gingival aspects. It is very important that the curing light be tested periodically with a light meter to ensure adequate light output.
   • Insert leveling wire and complete initial procedures. A light force wire (e.g., .016 NiTi or equivalent) is recommended at the initial bonding.
   • Note: Bonding ceramic brackets: Chemically-retentive bases must be etched and silanated. If not etched and silanated by the manufacturer, etch and silanate before bonding with GC Fuji ORTHO LC. If bracket bases become contaminated, follow the manufacturer’s directions for cleaning, and/or etching and silanating. No treatment is required for mechanically-retentive bases.
   • Bonding brackets to porcelain restorations: Prepare porcelain surfaces by etching and silanating according to the manufacturer’s directions. Bond with GC Fuji ORTHO LC as per above.
   • Bonding brackets to amalgam/metal alloy restorations: Lightly roughen the metal surface with a disc or a fine diamond point before placing GC Fuji ORTHO LC.
   • Acrylic Appliances
   • Using a micro etcher or a rotary instrument, roughen and place retention holes in the internal surfaces of the appliance.
   • Prepare the teeth as mentioned in section #1.
   • To facilitate the removal of the appliance, place petroleum jelly on the occlusal surfaces of the teeth.
   • Fill the internal surfaces of the appliance with GC Fuji ORTHO LC.
   • Seat into proper position.
   • Immediately remove excessive adhesive from the periphery of the appliance.
   • Moving the curing light tip in a distal-to-mesial direction, light-cure each side of the appliance for 30 seconds each on the buccal, palatal and occlusal surfaces.
   • Appliance activation can begin at the patient’s bedtime the same evening.

5. DEBONDING PROCEDURE

   • Brackets Grasp the bracket with a ligature cutter and, while supporting the tooth with fingers from the lingual side, give a sharp clockwise rotation to the bracket. If resistance is met, try again twisting in the opposite direction after desiccating (using an air syringe) the tooth around the bracket. Remove any residual adhesive with a scaler or rotary instrument.
   • Appliances To remove bonded appliances, flex the appliance in multiple sites with band-removing pliers. If this does not remove the appliance, section the appliance, desiccate the adhesive and remove the appliance.

STORAGE Recommended for optimal performance, store in a cool and dark place (4-25°C / 39.2-77.0°F).
PACKAGE Package: 50 Capsules Average contents per capsule: 0.30 g powder and 0.10 g (0.085 mL) liquid Minimum net volume of mixed adhesive per capsule: 0.1 mL Option: GC CAPSULE APPLIER (1 piece)

CAUTION

1. In case of contact with oral tissue or skin, remove immediately with a sponge or cotton soaked in alcohol. Flush with water.
2. In case of contact with eyes, flush immediately with water and seek medical attention.
3. In rare cases, the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a physician.
4. Personal protective equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.

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. Undesired effects- Reporting: If you become aware of any kind of undesired effect, reaction, or similar events experienced by the 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: vigilance@gc.dental In this way you will contribute to improving the safety of this product.

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