GC AMERICA 137106 Examix NDS Normal Setting A-Silicone Impression Material Instruction Manual

GC AMERICA 137106 Examix NDS Normal Setting A-Silicone Impression

Material

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

DESCRIPTION

EXAMIX NDS is a significantly advanced addition reaction (platinum catalyzed) VPS impression material. It produces crisp, extraordinarily smooth and highly precise impressions for models, crowns, bridges and dentures.

RECOMMENDED INDICATIONS AND USES

Indication| Impression Technique| Tray Type                       Recommended

Viscosities

---|---|---

Impression for facing, inlay, onlay, crown or bridge

| Single mix single impression| Monophase Monophase or Heavy +

Stock or                    Injection or Regular

Custom Tray Putty + Injection or Regular

Monophase or Heavy + Injection or Regular

Putty + Injection or Regular

Double mix single impression
Double mix double impression
Double mix single impression
Putty-Wash impression

Impression of partial denture

| Single mix single impression| Stock or Monophase

Custom Tray

Putty-Wash impression| Stock Tray Putty + Regular or Injection
Impression of full denture| Single mix single impression| Stock or Monophase

Custom Tray

CONTRAINDICATIONS

In rare cases, product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a physician.

PHYSICAL PROPERTIES (Average)

Test Items

| Injection Type 3: Light-Bodied Consistency| Regular Type 2:

Medium-Bodied Consistency

| Monophase Type 2: Medium-Bodied Consistency| Heavy Type 1:

Heavy-Bodied Consistency

---|---|---|---|---
Total Working Time (Min., Sec.)|

2’15”

|

2’00”

|

2’00”

|

2’00”

Minimum Time in Mouth (Min., Sec.)|

4’00”

|

4’00”

|

4’00”

|

4’00”

Recovery From Deformation (%)|

99.7

|

99.7

|

99.5

|

99.5

Maximum Strain

in Compression (%)

|

≤7.0

|

≤6.0

|

≤3.3

|

≤3.3

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))

DIRECTIONS FOR USE

Note: The cartridge and mixing tip provided are compatible with GC Cartridge Dispenser 2.

CARTRIDGE LOADING AND DISPENSING

1. Lift the release lever of the CARTRIDGE DISPENSER 2. (referred to as the dispenser hereafter) and pull the piston plunger all the way back into the dis-penser. Lift the cartridge holder of the dispenser and load the cartridge, ensuring that the V-shaped notch on the flange of the cartridge is facing down. Push the cartridge holder down to hold the cartridge firmly in place.
2. Lift the release lever and push the piston plunger forward until it engages into the cartridge.
3. Remove the cartridge cap by rotating 1/4 turn anti-clockwise. Tilt the cap downward and peel it away from the cartridge. Gently squeeze the dispenser handle to extrude a small amount of material from the two openings at the end of cartridge. Make sure that base and catalyst come out evenly.
4. Align the V-shaped notch on the rim of mixing tip to the V-shaped notch between the cartridge barrels. Push firmly to attach the mixing tip. Then rotate the colored collar of the mixing tip 1/4 turn clockwise to the end of the cartridge. The dispenser is now ready for use.
5. Squeeze the handle several times to extrude the material. After use, do not remove the mixing tip as this will become the storage cap until next use. When replacing the mixing tip, rotate the collar on the mixing tip 1/4 turn anti-clockwise to align the V-shaped notch on the cartridge. Tilt the mixing tip downward and peel it away from the cartridge.
6. Remove and replace the old mixing tip immediately prior to next use. Before attaching a new tip, gently extrude a small amount of material to ensure that base and catalyst are flowing evenly from both openings. If the materials should fail to extrude, remove any hardened materials from the end of the cartridge.
7. To replace the cartridge, lift the release lever and retract the piston plunger fully. Remove the empty cartridge by lifting the cartridge holder and load a new one into the dispenser.

USING THE IMPRESSION MATERIAL

Note: Prior to use, leave the material to stand at room temperature. Cooled or refrigerated material may delay setting.

1. Attach an intraoral tip to the mixing tip or load material into a syringe.
2. Inject the mixture onto the prepared teeth.
3. Load the tray with the appropriate material (putty, monophase, heavy body or regular – depending on technique being used).
4. Seat the loaded tray in the mouth within specified working times.
5. Wait for set (4 minutes in the mouth).
6. The obtained impression should be cleaned, then disinfected, utilizing a 2.5% or 3.4% glutaraldehyde, or another appropriate disinfectant, according to the manufacturers label recommendations.
7. Remove the impression and pour a model immediately (if desired). Maximum time for pouring the model is 14 days.

NOTES

1. When extruding EXAMIX NDS, 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
   • Latex
   • Eugenol materials
   • Oil
   • Sulfur
   • Acrylates
     Also avoid moisture and glycerol when extruding.

2. Avoid use of EXAMIX NDS with patients who have a history of hypersensitivity to silicone impression materials.

3. EXAMIX NDS can be silver-or copper-plated.

4. Care should be taken to avoid getting material on clothing. It is hard to remove. STORAGE Recommended for optimal performance, store at room temperature (74°F/23°C) @ 50% relative humidity.

PACKAGES

Note: All packaging types may not be available in all countries.
EXAMIX NDS 2 Cartridge Package with Tips

• Regular
• Injection
• Monophase
• Heavy

EXAMIX NDS 32 Cartridge Package Refill without Tips

• Regular
• Injection
• Monophase
• Heavy

EXAMIX NDS 80 Cartridge Package Refill without Tips

• Regular
• Injection
• Monophase
• Heavy

CAUTION

1. Avoid contact of base, catalyst, mixed material or adhesive with eyes. In case of contact, immediately flush with generous amount of water and -Regular seek medical attention.
2. Universal VPS Adhesive (optional) is flammable. Do not use or store near heat or open flame. Use in a well ventilated area.
3. Avoid getting material on clothing as it is hard to remove.
4. Personal protective equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.

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.
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/medicaldevices/contacts
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: 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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