ICONIC Alpha Retainer Material Instructions

June 12, 2024
ICONIC

ICONIC Alpha Retainer Material

ICONIC-Alpha-Retainer-Material-product

Product Information

The Alpha product is a dental material called Iconic Alpha, designed for use in various dental appliances such as retainers, aligners for tooth movement, bite planes, splints, snoring appliances, bruxing appliances, and nightguards. It is particularly suitable for individuals who grind or clench their teeth (bruxers/grinders) and for orthodontic treatment. The Iconic Alpha material offers benefits such as resistance to cracking and breaking, easy removal from the model, and easy trimming. It helps correct malocclusion and improves overall tooth health.

Product Usage Instructions

  1. Preheat the heating element until it turns into a solid orange color. Heating times may vary depending on current fluctuations or the length of time the heating element has been left on.
  2. Place the plastic into the frame of the vacuum machine and position the model on the base plate.
  3. After preheating, swing the heating element over the plastic.
  4. Observe the plastic as it heats.
  5. During heating, the Iconic Alpha material will rise toward the heat source and then become wavy as it lowers.
  6. Do not let the Iconic Alpha material sag.
  7. Move the heating element away from the plastic.
  8. Turn on the vacuum and lower the plastic over the model.
  9. Trim and finish the appliance as desired.
  10. If the plastic does not adapt to the model, add more heating time until adaption occurs. If the plastic folds when thermoformed, reduce heating times until it does not fold.
  11. The maximum sag of the Iconic Alpha material should not exceed 20mm when heating.

Please note that the heating times provided above are approximate and may vary depending on the specific machines used (Biostar Code and Drufomat). It is important to follow the instructions included with the machine for accurate heating times. After usage, the product should be disposed of according to the guidelines for the disposal of used devices. The Alpha product is intended for single use only and should be stored in a cool, dry place.

INTENDED USE

  • Iconic Alpha Material is is used in the manufacture of removable thermoformed appliances to fabricate intra-oral appliances such as retainers, aligners for tooth movement, bite planes, splints, snoring appliances, bruxing appliances and nightguards. Iconic Alpha material is especially suited for use with bruxers / grinders.

INDICATION

  • The dental appliances formed by the Iconic thermoforming appliances are indicated for use in patients requiring orthodontic treatment.

PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS

  • Performance characteristics of the Iconic thermoforming materials include strength, durability, clarity, resistant to cracking/breaking, easy to remove from model and easy to trim. The clinical benefits of the dental appliances formed from the Iconic material are the correction of malocclusion and an overall improvement in tooth health.

CONTRA-INDICATIONS

  • Patients with a history of allergic reactions to plastics should not use this product.

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.
  • Any serious incident that has occured in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

PRECAUTIONS

  • Patients with a history of allergic reactions to plastics should not use this product.
  • Store plastic sheets in a cool, dry place. Single use only.

ADVERSE REACTIONS

  • Allergic reactions.

DIRECTIONS FOR USE

  1. All models should be trimmed to 20mm (¾”) high. Full arch models should have the palate trimmed away.
  2. IMPORTANT: Pre-heat the machine before using! Preheat the vacuum machine for at least 3 minutes or until the heating element is a solid orange colour. (Heating times may vary with current fluctuations or length of time the heating element has been left on).
  3. Place the plastic into the frame of the vacuum machine and the model on the base plate.
  4. After preheating, swing the heating element over the plastic.
  5. Observe the plastic as it heats.
  6. During heating, Iconic Alpha material rises toward the heat source, then becomes wavy as it lowers from the raised position.
  7. The waves will start to flatten out into its original flat position – this is the optimal thermoforming time. Do not let the Iconic Alpha material sag.
  8. Move the heating element away from the plastic.
  9. Turn on the vacuum, then lower the plastic over the model.
  10. Trim and finish appliance as desired. Heating times may vary depending upon machines. If plastic does not adapt to model, add heating time until adaption occurs. If plastic “folds” when thermoformed, reduce heating times until material does not fold.

WHEN HEATING MAXIMUM SAG NO MORE THAN 20MM

Thickness **Vacuum Heat Time*** **Biostar Code*** **Drufomat***
0.75mm (.030”) 45 Seconds 152 85 Seconds
1.0mm (.040″) 60 Seconds 172 110 Seconds
1.5mm (.060”) 80 Seconds 220 150 Seconds
  • ***** After preheating machine

SAFE DISPOSAL

  • Used dental appliances may be considered a biohazard. Follow your country-specific laws, directives, standards and guidelines for the disposal of used devices.

CARE ADVICE FOR YOUR APPLIANCE

  • After brushing teeth brush the top and bottom of the retainer with a soft toothbrush
  • Do not brush appliance with toothpastes as this will significantly reduce the life of the appliance.
  • Use cold water to wash the retainer. The retainer can also be cleaned with Retainer Brite or similar cleaning solution
  • Hot water will distort the retainer
  • Rinse well before and after use and dry thoroughly
  • Handle the retainer with care and store in a retainer box when not in mouth
  • When removing the retainer apply equal pressure to all sides of the retainer – retainer retrievers recommended for this purpose
  • If the appliance becomes too tight do not force it, call your Orthodontist or Dentist
  • Do not eat or drink when wearing the retainer, as acids in food and drink can considerably reduce the life of the retainer

ICONIC-Alpha-Retainer-Material-fig-1

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References

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