EXAFLEX Hydrophilic Vinyl Polysiloxane Impression Material Instructions

Prior to use, carefully read
the instructions for use.

HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIAL
For use only by a dental professional in the recommended indications.

USES

Monophase

PHYSICAL PROPERTIES (Average)

Test Items| Injection
Type 3:
Low Viscosity| Regular
Type 2:
Medium Viscosity| Monophase
Type 2:
Medium Viscosity| Heavy
Type 1:
High Viscosity
---|---|---|---|---
Total Working Time (Min., Sec.)| 2’15”| 1’45”| 1’45”| 1’45”
Setting Time (Min., Sec.)| 4’00”| 4’00”| 4’00”| 4’00”
Minimum Time in Mouth (Min., Sec.)| 4’00”| 4’00”| 4’00”| 4’00”
Recovery From Deformation (%)| 100.| 100.| 100.| 99.
Maximum Strain
in Compression (%)| ≤7.0| ≤6.0| ≤3.3| ≤1.9
Linear Dimensional Change after
24 hrs (%)| ≤0.2| ≤0.2| ≤0.2| ≤0.2

Test conditions: Temperature (74˚F/23˚C ± 4˚F/2˚C) Relative humidity (50 ± 5%) (ISO 4823:1992(E))

CONTRAINDICATIONS

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

1. Squeeze equal lengths of Base and Catalyst onto the mixing pad.
2. Mix quickly with a spatula for about 30 seconds until a uniform color is obtained.
3. Collect the mixture and load it into the syringe.
4. Inject the mixture onto the prepared teeth.
5. Load tray with appropriate material (putty, monophase, heavy body, or regular depending on the technique being used.)
6. Seat the loaded tray in the mouth within the working time of each viscosity.
7. Wait for the appropriate set time.
8. After the material has been set, remove the impression and pour a model immediately (maximum time for pouring the model: 14 days).
9. The obtained impression should be cleaned, then disinfected, utilizing a 2.5% or 3.4% glutaraldehyde, or another appropriate disinfectant, according to the manufacturer’s label recommendations.

CAUTION

1. When mixing EXAFLEX, care should be taken to avoid mixing or contact with the following materials. They may delay or prevent setting.
   • Catalyst for condensation type silicone impression materials
   • Polysulfide impression materials
   • Latex
   • Eugenol materials
   • Oils
   • Sulfur
   • Acrylates
   Also, avoid moisture and glycerol when mixing.

2. After use, each type should be closed with its original cap.

3. Avoid the use of EXAFLEX with patients who have a history of hypersensitivity to silicone impression materials.

4. EXAFLEX can be silver-or copper-plated.

5. Care should be taken to avoid getting material on clothing. It is hard to remove when it sets up on clothes.

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

ADHESIVE (included in Regular Type Package) Used for EXAFLEX impressions with custom and stock trays, as well as the copper band tray technique. Clean the internal surface of the tray and dry thoroughly. Apply the adhesive agent uniformly using the attached brush or a cotton pellet. Let dry for about 5 minutes or blow dry completely. Load the EXAFLEX impression material.
Remarks: 1. This ADHESIVE can be used to adhere all viscosities of EXAFLEX to the tray. 2. After use, immediately replace the cap and store it in a cool place.

STORAGE

Recommended for optimal performance store at room temperature.
(74˚F/23˚C)@50 + – 10%) Relative humidity.

PACKAGES

| Standard (1 Tube ea. base, catalyst)| Clinic (20 Tube ea. base, catalyst)
---|---|---
| Regular| Injection| Heavy Body| Monophase| Regular| Injection| Heavy Body| Monophase
Base| 100g| 100g| 120g| 108g| 2000g| 2000g| 2400g| 2160g
Catalyst| 100g| 100g| 120g| 108g| 2000g| 2000g| 2400g| 2160g
Mixing Pad| 1| 1| 1| 1| | | |
Adhesive| 1| | | | | | |

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 product according to regional/national guidelines. 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 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.
Last revised: 02/2021

MANUFACTURED by GC CORPORATION
76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japan
Tel: +81-3-3965-1221
RESPONSIBLE MANUFACTURER IN CANADA:
GC AMERICA INC.
3737 West 127th Street, Alsip IL 60803 U.S.A.
DISTRIBUTED by GC AMERICA INC.
3737 West 127th Street, Alsip IL 60803 U.S.A.
Tel: +1-708-597-0900
www.gcamerica.com
EU: GC EUROPE N.V.
Researchpark Haasrode-Leuven 1240, Interleuvenlaan 33, B-3001 Leuven, Belgium
Tel: +32 16 74 10 00
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
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

References

• Country & Language Selector | GC Europe

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