GC America 000026 GC Fuji Varnish Self-Cured Glass Ionomer Sealant User Guide
- June 6, 2024
- GC AMERICA
Table of Contents
GC America 000026 GC Fuji Varnish Self-Cured Glass Ionomer Sealant User
Guide
RECOMMENDED INDICATIONS
For the prevention of water and saliva contamination to exposed surfaces of glass ionomer cements during the first 24 hours after placement.
CONTRAINDICATIONS
Avoid use of this product in patients with known allergies to acetate esters or acetone.
DIRECTIONS FOR USE
- Place the glass ionomer cement according to the manufacturer’s instructions.
- Using a cotton pellet or brush apply GC Fuji VARNISH to all exposed glass ionomer and adjacent surfaces.
- Dry by gently blowing with air syringe.
- Maintain moisture isolation for 2-3 minutes.
Note: GC Fuji VARNISH is volatile. Close bottle immediately after use.
STORAGE
Recommended for optimal performance, store at temperature of 4-25°C (39.2-77.0°F).
PACKAGE
Bottle of 10 g (10.4 mL)
CAUTION
-
GC Fuji VARNISH is FLAMMABLE. Avoid sources of ignition and do not store in
direct sunlight. -
In case of contact with oral tissue or skin, remove immediately with a sponge or cotton soaked in alcohol. Flush with water.
-
In case of contact with eyes, flush immediately with water and seek medical attention.
-
Personal protective equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.
-
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 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.
Last revised: 05/2021
MANUFACTURED by GC ASAHI CORP.
1-3-3 Kachigawa-cho, Kasugai, Aichi 486-0945, 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,
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