Gradia Direct – microfilled hybrid composite resin

Gradia Direct – light-cured composite restorative

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

Gradia Direct

Recommended indications
A.Gradia Direct anterior
1. Direct restorative for Class III, IV, V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.

B.Gradia Direct posterior (radiopaque)
1. Direct restorative for Class I and II cavities

Contraindications:
1. Pulp capping.
2. 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.

Directions for use Gradia Direct

1. Shade Selection
Clean the tooth with pumice and water. Shade selection should be made prior to isolation. Select the appropriate Gradia Direct shades by referring to the Gradia Direct shade guide.

2. Cavity Preparation
Prepare cavity using standard techniques.

Note :
For pulp capping, use calcium hydroxide.

3. Bonding Treatment
For bonding Gradia Direct to enamel and / or dentin, use a light-cured bonding system such as GC Fuji BOND LC, GC UniFil Bond, or GC G-aenial Bond. Follow manufacturer’s instructions.

4. Placement of Gradia Direct
1) Dispensing from a Unitip
Insert the Gradia Direct Unitip into the Unitip APPLIER or equivalent. Remove the cap and extrude material directly into the prepared cavity. Use steady pressure. Maintain pressure on the applier handle while removing the Unitip APPLIER and Unitip from the mouth. This prevents the Unitip from coming loose from the applier.

2) Dispensing from a syringe
Remove syringe cap and dispense material onto a mixing pad. Place the material into the cavity using a suitable placement instrument. After dispensing, screw syringe plunger anticlockwise by a half to full turn to release residual pressure inside the syringe. Replace cap immediately after use.

Note :
1.Basically, material can be applied in a single layer to achieve aesthetic restorations using Standard shades. For details, refer to the Clinical Hints.
2.Material may be hard to extrude immediately after removing from cold storage. Prior to use, leave to stand for a few minutes at normal room temperature.
3.After dispensing, avoid too long an exposure to ambient light. Ambient light can shorten the manipulation time.

Clinical Hints Gradia Direct

1. Anterior cavities
a. In the case of small cavities
Restore using a one shade layering technique. In most cases the use of one Standard shade alone will be sufficient. In cases where a higher degree of translucency is needed, one of the Outside special shades can be selected. See also Examples of Clinical Applications.

b. In the case of large cavities
In most cases a multi shade layering technique will give the best aesthetic results. To block out shine throughs from the oral cavity or to mask discoloured dentin, select an appropriate Inside special shade and continue to build up with a Standard shade.

To make a restoration more life like e.g. to copy age related changes in appearance, the final layer should consist of an Outside special shade. See also Examples of Clinical Applications and / or consult the Shade Combination Chart.

2. Posterior cavities
a. In the case of small cavities
Restore using a one shade layering technique. In most cases the use of one Standard shade alone will be sufficient. In cases where a higher translucency is needed, one of the Outside special shades can be selected. See also Examples of Clinical Applications.

b. In the case of deep cavities
Place a flowable composite such as GRADIA DIRECT Flo or GRADIA DIRECT LoFlo* on the cavity floor. Then place a Standard shade. For optimal aesthetics use an Outside special shade as the final composite layer. See also Examples of clinical applications.

*GC Fuji LINING® PASTE PAK, GC Fuji LINING® LC or GC Fuji IX GP can also be used as a liner or base material. Follow the respective manufacturer’s instructions for use.

Examples of Clinical Applications (Clinical Hint No.1, 2)
gr1

Shade combination chart for multiple layers in large cavities of anterior teeth (1-b)
gr2

5. Contouring before Light Curing
Contour using standard techniques.

6. Light Curing
Light cure GRADIA DIRECT using a light curing unit
Refer to the following chart for Irradiation Time and Effective Depth of Cure.

GRADIA DIRECT ANTERIOR: Irradiation Time and Effective Depth of Cure

gr3

GRADIADIRECT POSTERIOR : Irradiation Time and Effective Depth of Cure

gr4

Note :
1. Material should be placed and light cured in layers. For maximum layer thickness, please consult the tables.
2. Lower light intensity may cause insufficient curing or discoloration of the material.

7. Finishing and Polishing
Finish and polish using diamond burs, polishing points and discs. To obtain a high gloss, polishing pastes can be used.

Cleaning and Sterilizing of the Unitip APPLIER
1. Clean the applier with gauze soaked in alcohol.
2. The applier may be steam autoclaved at 121-135°C (250-275°F) for 10 to 30 minutes or disinfected using alcohol.
Note :
1)Do not attempt to sterilize in a unit at a temperature that exceeds 135°C (275°F) during the drying step of the autoclave procedure. Otherwise, the applier may be damaged.
2)The use of various chemical disinfectants / sterilants may cause damage to the applier and therefore is not recommended.

Cleaning of the Shade Guide
The shade guide can be cleaned with water and mild soap. It should not be sterilized. The use of various chemical disinfectants / sterilants may cause damage to the shade guide.

Shades
1. 22 shades for anteriors
Standard shade : XBW (Extra Bleaching White), BW (Bleaching White), A1, A2, A3, A3.5, A4, B1, B2, B3, C3, CV (Cervical), CVD (Cervical Dark)
Inside special shade : AO2, AO3, AO4
Outside special shade : WT (White Translucent), DT (Dark Translucent), CT (Clear Translucent), NT (Natural Translucent), GT(Gray Translucent), CVT (Cervical Translucent)

2. 6 shades for posteriors
Standard shade : P-A1, P-A2, P-A3, P-A3.5,
Outside special shade : P-WT (White Translucent),P-NT (Natural translucent)

Note :
A, B, C, AO shades are based on Vita * Shade.

*Vita is a registered trademark of Vita Zahnfabrik, Bad Säckingen, Germany.

Packages
I. Unitips
1. INTRODUCTORY KIT
(35 Unitips in 7 shades)
– 35 tips (5 tips each in 7 shades) (0.16mL per tip)
(6 anterior shades : A2, A3, A3.5, AO3, CV, CT)

(1 posterior shade : P-A2)
– Shade guide

2. REFILL
a.Pack of 20 tips (each in 14 shades) (0.16mL per tip)
(8 anterior shades -A1, A2, A3, A3.5, AO3, CV, NT, DT)
(6 posterior shades-P-A1, P-A2, P-A3, P-A3.5, P-WT, P-NT)
b.Pack of 10 tips (each in 14 shades) (0.16mL per tip)
(14 anterior shades – XBW, BW, A4, B1, B2, B3, C3, AO2, AO4, CVD, CT, WT,GT,CVT)

Note :
Weight per Unitip : 0.24g for anterior tip, 0.28g for posterior tip
3. Option
a.Unitip APPLIER b. Shade guide c. Mixing pad (No.14B)

II. Syringes
1. INTRODUCTORY KIT
– 7 syringes (1 each in 7 shades) (2.7mL per syringe)
(6 anterior shades : A2, A3, A3.5, AO3, CV, CT)
(1 posterior shade : P-A2)
– Shade guide

2. REFILL
– 1 syringe (in 28 shades) (2.7mL per syringe)

Note :
Weight per syringe : 4.0g for anterior syringe, 4.7g for posterior syringe

3. Option
a.Shade guide b. Mixing pad (No.14B)

CAUTION
1. In case of contact with oral tissue or skin, remove immediately with cotton or a sponge soaked in alcohol. Flush with water.
2. In case of contact with eyes, flush immediately with water and seek medical attention.
3. Take care to avoid ingestion of the material.
4. Wear plastic or rubber gloves during operation to avoid direct contact with air inhibited resin layers in order to prevent possible sensitivity.
5. For infection control reasons, Unitips are for single use only.
6. Wear protective eye glasses during light curing.
7. When polishing the polymerised material, use a dust collector and wear a dust mask to avoid inhalation of cutting dust.
8. Do not mix with other similar products.
9. Avoid getting material on clothing.
10.In case of contact with unintended areas of tooth or prosthetic appliances, remove with instrument, sponge or cotton pellet before light curing.
11.Do not use Gradia Direct in combination with eugenol containing materials as eugenol may hinder Gradia Direct from setting.

MANUFACTURED BY
GC DENTAL PRODUCTS CORP. 2-285, Toriimatsu-cho, Kasugai, Aichi 486-0844, Japan

CATEGORY Composite
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