GC AMERICA GC Fuji LINING LC Radiopaque Light Cured Glass Ionomer Lining Cement Instructions

GC Fuji LINING™ LC
RADIOPAQUE LIGHT CURED GLASS IONOMER LINING CEMENT

Prior to use, carefully read the instructions for use.

For use only by a dental professional in the recommended indications.
RECOMMENDED INDICATIONS
As a base or liner in prepared cavities.

CONTRAINDICATIONS

1. Pulp capping.
2. Avoid the use of this product in patients with known allergies to glass ionomer cement, methacrylate monomer, or methacrylate polymer.

DIRECTIONS FOR USE

1. POWDER AND LIQUID DISPENSING
   a) The standard powder to liquid ratio is 1.4/1.0 g. 1 level scoop of powder to 1 drop of liquid.
   b) For accurate dispensing of powder, lightly tap the bottle against the hand.
   Do not shake or invert.
   c) Hold the liquid bottle vertically and squeeze gently.
   d) Close bottles immediately after use.

2. MIXING
   Dispense powder and liquid onto the pad. Using the plastic spatula, divide the powder into two equal parts. Mix the first portion with all of the liquid for 5-10 seconds. Incorporate the remaining portion and mix the whole thoroughly for 10-15 seconds.

3. RESTORATIVE TECHNIQUE
   a) Prepare tooth using standard techniques. Extensive mechanical retention is not necessary.
   b) Wash and dry but DO NOT DESICCATE. CAVITY CONDITIONER or DENTIN CONDITIONER is recommended to remove the smear layer.
   For pulp, capping uses calcium hydroxide.
   c) Mix the required amount of cement. Working time is 3 minutes from the start of mixing at 23°C (73°F). Higher temperatures will shorten working time.
   d) Remove surface moisture, but DO NOT DESICCATE.
   e) Transfer cement to the preparation using a syringe or suitable placement instrument, covering the dentine up to the dentin-enamel junction.
   f) Light cure with a suitable visible light curing device (470 nm wavelength) for 30 seconds. Place light source as closely as possible to the cement surface.
   Note:
   If the application exceeds 1.6 mm in depth, use a layering technique.
   g) Proceed with standard composite or amalgam restorative techniques.

STORAGE
Recommended for optimal performance, store in a cool and dark place (4-25°C) (39.2-77.0°F).

PACKAGES

1. Bottle of 10 g powder with scoop.
2. Bottle of 8 g (6.8 mL) liquid.
3. 1-1 pkg. : 10 g powder, 8g (6.8 mL) liquid, powder scoop, plastic spatula, mixing pads.

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. DO NOT mix powder or liquid with any other glass ionomer components.
4. Personal protective equipment (PPE) such as gloves, face masks, and safety eyewear should always be worn.
5. 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.

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 inspects the device and label it for deterioration. Discard the 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
the 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 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: [email protected] In this way you will contribute to improving the safety of this product.
Last revised: 06/2021

MANUFACTURED by GC CORPORATION
76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japan
RESPONSIBLE MANUFACTURER IN CANADA:
GC AMERICA INC.
3737 West 127th Street, Alsip, IL 60803 U.S.A.
EU : GC EUROPE N.V.
Researchpark Haasrode-Leuven 1240, Interleuvenlaan 33, B-3001 Leuven, Belgium TEL: +32 16 74 10 00
PRINTED IN JAPAN
TEL: +1-708-597-0900
www.gcamerica.com
GC SOUTH AMERICA
Rua Heliodora, 399, Santana – SP, BRASI
CEP: 02022-051 – TEL: +55-11-2925-0965
CNPJ: 08.279.999/0001-61

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

References

• Country & Language Selector | GC Europe

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