Dentsply Sirona Essix ACE Directions For Use Manual

Essix ACE® Plastic
DIRECTIONS FOR USE
INTENDED USE:
Essix ACE® Plastic is thermoformed to fabricate intra-oral appliances such as retainers, aligners for minor tooth movement, and temporary bridges. Essix
ACE® Plastic is suitable for use with non-bruxers.
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 effortless to trim.
Clinical benefits of tooth whitening and aligner treatment may include overall improvement of tooth health and correction of malocclusion(s).
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:
Do not reuse plastic sheet. Once thermoformed it cannot be reused.
Essix ACE® Plastic is not recommended for bruxers.
Patients with a history of allergic reactions to plastics should not use this product.
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. Essix ACE® Plastic has a protective film on both sides. REMOVE FILM FROM BOTH SIDES BEFORE THERMOFORMING.
2. All models should be trimmed to ¾" high. Full arch models should have the palate trimmed away.
3. Spray the model with Trim-Rite® Release Agent to prevent the material from sticking to the model.
4. Place the plastic into the frame of the machine and the model on the base plate.
5. Scan/Enter the code per thermo-forming machine used. Swing the heating element over the plastic and press the appropriate start button.
6. Move the heating element away from the plastic when the heating and cooling time expires.
7. Drufomat: hold the element away and press the button on the side to engage the pressure chamber. Biostar: flip the heated plastic over the model.
8. After the cooling stage, release the pressure per thermo-forming machine used.
9. Remove the formed tray from the frame of the machine.
10. Trim and finish the appliance as desired.
*NOTE: 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
0.75mm (.030")
0.88mm (.035")
1.0mm (.040")
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
Drufomat
113 1:00
123 1:05
133 1:10
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
MKT-DFU0036-ML Rev. 03 Issued 05-2021
Biostar and Drufomat are not trademarks of
Dentsply Sirona.
©2021 Dentsply Sirona
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