ICONIC DBL4-101-1063 Lux Retainer Aligner Material Instructions

ICONIC DBL4-101-1063 Lux Retainer Aligner Material

Product Information

The Lux Retainer/Aligner Material is a dental appliance material suitable for various applications such as retainers, aligners for tooth movement, bite planes, splints, snoring appliances, bruxing appliances, and nightguards. The material, known as Iconic Lux, is specially designed for use with individuals who grind their teeth (bruxers/grinders) and is commonly used in orthodontic treatment. It offers advantages such as resistance to cracking and breaking, easy removal from the model, and easy trimming. Dental appliances made from Iconic Lux material help correct malocclusion and improve overall tooth health.

It is important to note that the use of this product should comply with the regulations and guidelines set by the competent authority of the Member State where the user and/or patient is established. The product does not contain Bisphenol A (BPA), a chemical compound often associated with health concerns.

Product Usage Instructions

1. Iconic Lux is supplied with an easy-peel heat-resistant protective film on both surfaces of the blank.
2. For best results, preheat the machine according to the recommended settings. Refer to the machine’s instructions for specific heating times.
3. Place the Iconic Lux blank on the model or appliance former.
4. Apply heat using a suitable machine or equipment. Heating time may vary, so ensure that the material adapts fully to the model. If the material folds when thermoformed, reduce the heating time until this issue no longer occurs.
5. After the heating process, remove the heat-resistant film from Iconic Lux.
6. Trim and finish the appliance as needed. For best results, use an Iconic Polishing Disk.
7. Depending on the desired thickness, refer to the table below for vacuum heat time recommendations:

Please note that the product is intended for single use only. After use, it is recommended to store it in a cool dry place. The package includes detailed instructions for use. If you have any further questions or concerns, please contact DB Lab Supplies using the contact information provided below.

DB Lab Supplies

• Ryefield Way, Silsden, West Yorkshire, BD20 0EF, United Kingdom
• T: +44 (0) 1535 656 999
• F: +44 (0) 1535 656 969
• E: sales@dblabsupplies.co.uk
• Web: www.dblabsupplies.co.uk

IFU040 – Issue 3 – 22/06/2023.

INTENDED USE
Iconic Lux 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 Lux 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, resistance to cracking/breaking, easy of removal from the model and easy of trimming. 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

• Iconic Lux is formed at extremely high temperatures, care must be taken when thermoforming.
• When thermoforming never leave the machine unattended.
• Excessive heating of Iconic Lux may result in the material deteriorating resulting in reduced patient wear time.
• Any serious incident that has occurred 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

• Iconic Lux should be stored between 5˚C – 25˚C, in a dry place.
• Keep away from direct sunlight, if exposed for prolonged periods material could become prone to degradation and discoloration.
• Iconic Lux should only be used as outlined in the indications of use, any use of Iconic Lux inconsistent with these indications of use is at the discretion and sole responsibility of the practitioner.
• Patients with a history of allergic reactions to plastics should not use this product. Iconic Lux does not contain Bisphenol A (BPA).

ADVERSE REACTIONS

• Allergic reactions.

DIRECTIONS FOR USE

1. Iconic Lux is supplied with an easy-peel heat-resistant protective film on both surfaces of the blank. For best results remove the film on the heat contact surface of the blank, leaving the film on the model contact surface of the blank. This will prevent the need to isolate the model, improving clarity. This also creates a micro gap preventing the need to block out minor undercuts.
2. The model should be trimmed to a depth of 20mm (3/4”) in height.
3. Remove the palate of full arch models.
4. Vacuum / Pressure form using a machine conventionally used for thermoforming.
5. Ensure Iconic Lux has cooled before removing material from the model. For best results use Iconic Tricutter DBL4-101/1063 or Iconic Wheel Saw DBL4-0150.
6. Remove heat-resistant film from Iconic Lux
7. Trim and finish appliances as needed. For best results use Iconic Polishing Disk 4S04-1381.

Heating time may vary on the machine. If Iconic Lux does not adapt to the model, add heating time until full adaptation occurs. If Iconic Lux“folds” when thermoformed, reduce heating time until this does not occur.

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 your teeth brush the top and bottom of the retainer/aligner with a soft toothbrush
• Do not brush the retainer/aligner with toothpaste as this will significantly reduce the life of the retainer.
• Use cold water to wash the retainer. The retainer can also be cleaned with Retainer Brite or a similar cleaning solution
• Hot water will distort the retainer
• Rinse well before and after use and dry thoroughly
• Handle the retainer/aligner with care and store it in a retainer box when not in the mouth
• When removing the retainer/aligner apply equal pressure to all sides of the retainer – retainer retrievers are 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/aligner, as acids in food and drink can considerably reduce the life of the retainer/aligner

DB Lab Supplies
Ryefield Way, Silsden, West Yorkshire, BD20 0EF, United Kingdom

• T: +44 (0) 1535 656 999
• F: +44 (0) 1535 656 969
• E: sales@dblabsupplies.co.uk
• Web: www.dblabsupplies.co.uk.

References

• DB Lab Supplies

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