Thermoforming Sheet

Indication For Use

Product name: Thermoforming Sheet

Key performance:

• Tensile modulus: ≥500 MPa
• Yield stress: ≥20MPa
• Yield strain: ≥3 %
• Angle tear strength: ≥80 MPa

Product composition: Polyurethane – copolyester composite

Intend use: Maxflex Themoformable Sheets are intended for prescription use in the fabrication of orthodontic and dental appliances.

Contraindication: It is forbidden for those who are allergic to the material of this product.

Intend user: Trained production personnel

Intend patients: Adults and teenagers

Caution

1. After the product is unsealed, the aluminum foil bag containing the remaining sheets should be sealed in time. Do not use the product if the aluminum foil bag is damaged.

2. 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.

Method of use

1. Open the aluminum foil bag, take out a thermoforming sheet and fix it in the frame of the press machine, and place the tooth mold to be pressed at the bottom.

2. Move the heating element above the sheet and press the sheet under appropriate thermoforming conditions (refer to the thermoforming parameters in below table). Remove heating element after molding.

3. Cool down.

4. Demould and trim the thermoformed article.

Storage and transportation conditions

The storage should be ventilated and the relative humidity must be no more than 80%.

Shelf life: 3 years.

Technical Support

CF (Comfortable Series): The CF series products are made of medical-grade elastic materials, which are easy to press or vacuum-forming and cut into shapes, With proper biomechanical strength and improved tear resistance compared with the ST series. It is more comfortable to wear.

ST (Standard Long-lasting Retention Series): Produced from ultra-high hardness thermoplastic polyurethane (TPU) materials. They have an excellent stress retention rate, outstanding tear resistance, and giving an exceptional correction effect.

ML (Multilayer Series): Multi-layer dental coping sheets are designed according to different clinical needs, exhibit balanced biomechanical properties, and can provide physicians and patients with comprehensive options.

FN (Special Functional Series): The R&D team has created a new series of drug loading sheets and anti-bruxism products, which provide a comprehensive solution for dental health care.

Dental coping sheets

Dental coping sheets is a high-performance material specially designed for dental orthodontics. Our products are optimized for high strength retention ratio, ductility, tear resistance, stain resistance, and transparency based on material science. Compared with other materials, our products provide better dental treating and nursing functions.

Dental coping rolls

Dental coping rolls are made of high-performance thermoplastic polyurethane material. It has excellent biocompatibility, stress maintenance, stain resistance, and tear resistance. It is the best material for making orthodontic appliances and retainers.

Instructions-1: Model preparation

• The model should be completely cured and dry.
• The model should be trimmed to be approximately 20-25mm.
• Any special molding machine accessories should be assembled and placed with positive or negative pressure.
• Applying medical release agent to the model is recommended (to prevent the appliance from sticking to the model).
• Positive pressure (4 to 6 kg/cm2) thermoforming machine is recommended/negative pressure thermoforming machine vacuum thermoforming machine:
  • Turn on the thermoforming machine, enter the reference code, and set the appropriate heating temperature and time (Please refer to the table of thermoforming parameters).
  • Adjust the appropriate vacuum degree for thermoforming (a complicated sheet usually requires a high vacuum degree)
  • Place the model on the forming platform and adjust it to an appropriate position.

Instructions-2

• Open the foil bag and place the thermoformable sheet on the thermoforming frame (the thermoformable sheet needs to be used up within 15 minutes after opening the foil bag).
• Swing the heating unit (usually Tungsten wire heating hood) over the thermoformable sheet to start heating until the sheet sags by approximately 12 to 20 mm.
• Move the heating unit away from the thermoformable sheet.
• Use air press or vacuum suction to form the thermoformable sheet onto the model and then cool it down before handling.
• Trim and finish the appliance.
• Clean the appliance with a mild detergent that complies with medical specifications. (please clean it under 40°C)

Table of thermoforming parameters

• These are recommended thermoforming parameters for thermoformable sheet materials.
• The heating time varies between different machines.
• If the sheet doesn't form well according to the model, the heating time can be increased by 3-5 seconds until the appliance is well-formed.
• If the sheet sags to form wrinkles or abnormal deformation, reduce the heating time until no wrinkles or abnormal deformation occurs.
• The thermoformable sheet should be used within 15 minutes after opening the foil bag. If bubbles form in the process of plastic heating and sagging, it means that the sheet has absorbed water. Please replace it with a new thermoformable sheet.
• Design can have many variations, learning to make perfect appliances with this material may require some additional guidance and technical communication.

Trimming instructions

• Use a trimming wheel or a twist drill to cut the appliance off the model.
• Operate the trimming wheel or twist drill (recommended diameter is approximately 1mm) at approximately 20,000- 30,000 rpm and cut as close as possible to the finished outline of the appliance. (At least 3mm away from the gingiva is suggested.)
• Use an edge polisher to polish the edges of the appliance.
• Finally, clean the appliance with a mild detergent that complies with medical specifications. (please clean it under 40 °C)

Attention

Contraindications: Patients with a history of allergic reaction to plastics should avoid this material. Caution: if the thermoformable sheet is heated overtime during thermoforming, the plastic may sag and may cause skin burns to technicians. Please wear appropriate protective equipment.

Medical disclaimer

• The test conforms to IS010993, proving the standardization of products. Furthermore, independent tests were conducted for biocompatibility, such as cytotoxicity, system injection, and intradermal and intramuscular implantation.
• Considering the unique nature of each application and the fact that equipment manufacturing depends on the materials, thermoforming machines, molds, and the skills of technicians, we guarantee that sheets meet our strict specifications.
• Information related to dental, medical, and health conditions or related products and treatments are for reference only and should not be considered professional medical advice or diagnosis, nor should it be used or regarded as a substitute for professional medical treatment consultation, advice, diagnosis, or treatment. This information should not be considered comprehensive because it does not cover all possible conditions, diseases, treatments, and medical information.
• The information on this website may not be used to modify, obstruct, or prohibit any existing or prescribed medical professional treatment. We encourage you to contact us regarding the use of materials.