DB Lab Iconic Splint Instruction Manual

DB Lab Iconic Splint

Specifications:

• Product Name: Iconic Splint
• Thickness Options: 2mm, 3mm
• Heating Times:
  • Iconic VF1 – 2mm: 90 Sec Heat, 3mm: 120 Sec Heat
  • Iconic PF1 – 2mm: 90 Sec Heat/45 Sec Cool, 3mm: 120 Sec Heat/60 Sec Cool
  • Biostar Code* – 65 Sec (194), 80 Sec (227)
  • Drufomat* – 110, 140
• Manufacturer: DB Lab Supplies

Product Usage Instructions

DIRECTIONS FOR USE:

1. Iconic Splint comes with a protective film on both surfaces. Choose between thin (clear) or thick (blue) film based on preference.
2. Keep the film on the model contact surface during thermoforming for best clarity and aesthetics.
3. Use a model that is no more than 20mm in height for thermoforming.
4. For full arch models, remove the palate section.
5. Thermoform using a vacuum/pressure machine suitable for thermoforming.
6. Allow Iconic Splint to cool before removing from the model. Use Iconic Tricutter DBL4-101/1063 for best results.
7. Remove the heat-resistant film from Iconic Splint after thermoforming.
8. Trim and finish the appliance using the recommended tools: Cool Tungsten Fine Bur (DBL4-84T/XXF) for edges, and Iconic Polishing Disk for polishing.
9. Iconic Splint can bond with cold cure ortho resin for additions.

SUGGESTED HEATING TIMES:
Heating times may vary based on the machine used. Adjust heating time if needed for proper adaptation and to prevent folding during thermoforming. Ensure the material does not sag more than 20mm.

Storage and Disposal:

• Single-use only
• Store in a cool dry place

Contact Information:

• DB Lab Supplies, Ryefield Way, Silsden, West Yorkshire, BD20 0EF, United Kingdom
• Phone: +44 (0) 1535 656 999
• Email: sales@dblabsupplies.co.uk
• Website: www.dblabsupplies.co.uk

Instructions included
IFU046 – Issue 1 – 09/05/2024

FAQ:

• Q: Can Iconic Splint be reused?
  A: No, Iconic Splint is designed for single use only.

• Q: What should I do if the material folds during thermoforming?
  A: Reduce the heating time until folding does not occur. Ensure proper adaptation to the model.

INTENDED USE
Iconic Splint is used in the manufacture of removable thermoformed dental appliances such as hard splints, drilling guides & mouthguards

INDICATION
The dental appliances formed by Iconic Splint are indicated for use in patients requiring dental treatment.

PERFORMANCE CHARACTERISTICS AND CLINICAL BENEFITS

Performance characteristics of Iconic Splint include strength, durability, comfort, clarity, resistance to fracture, easy of process and finish. The clinical benefits of thermoformed appliances made from Iconic Splint are the correction and an overall improvement in dental-related health.

CONTRA-INDICATIONS

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

WARNINGS

• Iconic Splint is formed at extremely high temperatures; care must be taken when thermoforming.
• When thermoforming never leave the machine unattended.
• Excessive heating of Iconic Splint may result in the material cracking, fracturing, and reduced patient wear time.
• Any serious incident that has occurred concerning the appliance 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 Splint 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 discolouration.
• Iconic Splint should only be used as outlined in the indications of use, any use of Iconic Splint 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 Splint does not contain Bisphenol A (BPA).

ADVERSE REACTIONS
Allergic reactions.

DIRECTIONS FOR USE

1. Iconic Splint is supplied with a heat-resistant protective film on both surfaces of the blank. The clear film is thinner, the blue film is thicker. The user can decide if they require a thin or thick spacer film. For best clarity leave the film on the model contact surface during thermoforming. This will prevent the need to isolate the model, improving appliance aesthetics. This also creates a micro gap in the thermoformed appliance, preventing the need to block out minor undercuts.
2. The model used for thermoforming should be no more than 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 Splint has cooled before removing material from the model. For best results use Iconic Tricutter DBL4-101/1063.
6. Remove heat-resistant film from Iconic Splint
7. Trim and finish appliances as required. For best results use Cool Tungsten Fine Bur (DBL4-84T/XXF) to trim edges, then Iconic Polishing Disk Coarse Brown (4S04-1384) 1st polish, 2nd polish with Medium Grey (4S04-1382).
8. Iconic Splint takes additions (chemical bond) cold cure ortho resin

SUGGESTED HEATING TIMES

Heating times may vary on the machine. If Iconic Splint does not adapt to the model, add heating time until full adaptation occurs. If Iconic Splint “folds” when thermoformed, reduce the heating time until this does not occur. When heating the Iconic Splint, ensure the material does not sag more than 20mm.

Thickness| Iconic VF1| Iconic PF1| Biostar Code| Drufomat
---|---|---|---|---
2mm| 90 Sec Heat| 90 Sec Heat / 45 Sec Cool| 65 Sec (194)| 110
3mm| 120 Sec Heat| 120 Sec Heat / 60 Sec Cool| 80 Sec (227)| 140

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

• Brush the top and bottom of the appliance with a soft toothbrush.
• Do not brush using toothpaste as this will significantly reduce the life of the appliance.
• Use cold water to wash the appliance. The appliance can also be cleaned with Retainer Brite or a similar cleaning solution, rinse the appliance under cold water to ensure the cleaning solution is not remaining before the appliance enters the mouth.
• Hot water will distort the appliance.
• Handle the appliance with care and store it in a retainer box when not in the mouth.
• When removing the appliance apply equal pressure to all sides of the appliance – retainer retrievers recommended for this purpose. See Orthostore website www.orthostore.co.uk
• If the appliance becomes too tight do not force it, call your Dentist.
• Do not eat or drink when wearing the appliance, as acids in food and drink can considerably reduce the life of the appliance.

Contact Information

DB Lab Supplies

• Ryefield Way, Silsden, West Yorkshire, BD20 0EF, United Kingdom
• 44 (0) 1535 656 999
• sales@dblabsupplies.co.uk
• www.dblabsupplies.co.uk.

References

• Orthostore | orthodontic accessories

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