Dentsply Sirona Essix Dual Laminate Plastic Directions For Use Manual

Essix® Dual Laminate Plastic
INSTRUCTIONS FOR USE
INTENDED USE:
Essix® Dual Laminate is thermoformed to fabricate intra-oral appliances such as TMJ splints, nightguards, and clenchers & grinders. Essix® Dual Laminate is
suitable for use with bruxers/grinders.
INDICATIONS FOR USE:
Mouthguard and aligner materials are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards,
nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS:
Performance characteristics of orthodontic plastics include a good combination of strength, durability and clarity, resistant to cracking or breaking, easily
removeable from models and easy to trim.
Clinical benefits of orthodontic treatment may include overall improvement of tooth health and correction of malocclusion.
CONTRAINDICATIONS:
This product is contraindicated for patients with a history of allergic reactions to plastics.
WARNINGS:
Excessive heating time during thermoforming will cause plastic to over sag and potential for injury to operator.
Improper thermoforming of the plastic appliance may cause the appliance to crack/break, resulting in sharp edges, loose pieces and possible aspiration of
pieces.
Report serious incidents that have occurred in relation to the device to device manufacturer and the Competent Authority in Member State of residence,
or other applicable regulatory agency
PRECAUTIONS:
Patients with a history of allergic reactions to plastics should not use this product.
Do not reuse plastic sheet. Once thermoformed it cannot be reused.
Thermoformed device is for Single Patient Use. Risks of reuse include infection and contamination (i.e. bacterial, viral).
Store plastic sheets in a cool, dry place.
ADVERSE REACTIONS:
Allergic reactions.
STEP BY STEP INSTRUCTIONS:
Thermoforming Instructions (for complete instructions, refer to thermoforming equipment manual):
1. All models should be trimmed to ¾" high. Full arch models should have the palate trimmed away.
2. Spray the model with Trim-Rite® Release Agent to prevent the material from sticking to the model.
3. Place the plastic into the frame of the vacuum machine soft side up and the model on the base plate.
4. Scan/Enter the code per thermo-forming machine used. Swing the heating element over the plastic and press the appropriate start button.
5. Move the heating element away from the plastic when the heating and cooling time expires.
6. Biostar: flip the heated plastic over the model.
7. After the cooling stage, release the pressure per thermo-forming machine used.
8. Remove the formed tray from the frame of the machine.
9. Trim and finish appliance as desired.
COMMON PROBLEMS:
Not heating the soft side long enough.
Heating the hard side too long – it will become yellow and burn.
SPECIAL NOTES:
The edges of Dual Laminate sheets may appear rough. This is normal and will not affect the function of the plastic. Cold cure acrylic may be applied to the
hard side only. Roughen the surface of the desired area prior to applying the monomer. Beware that the monomer does not get on the soft side of the
material – it will burn (yellow).
The heating times below should be used as a reference as heating times may vary depending upon machine usage. If plastic does not adapt to model, add
heating time until adaptation occurs. If plastic "folds" when thermoformed, reduce heating time until material does not fold.
Thickness Biostar™ Code
2.0mm (.080") Soft – 151 (Triple Flip)
Hard – 105 (Triple Flip)
3.0mm (.120") Soft – 231 (Triple Flip)
Hard – 115 (Triple Flip)
Note: (Triple Flip) is for Biostar™ process only: Heat soft surface, then flip and heat hard surface, then flip back to the soft surface before pressure forming.
Not recommended for use in a Drufomat.
SAFE DISPOSAL:
Unused plastic sheets can be recycled.
Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used
devices.
Manufacturer: Dentsply Sirona Orthodontics Inc.
7290 26th Court East Sarasota, FL 34243 USA
www.dentsplysirona.com/ifu
MKT-DFU0037-ML Rev. 02 Issued 03-2021
Biostar is not a trademark of Dentsply Sirona.
©2021 Dentsply Sirona
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