BionFlex- Multi-layer Thermoplastic Polyurethane (TPU) Material
Legacy develops, produces and sells high-quality TPU dental orthodontic sheets of various specifications. The sheet has high toughness and strength, and is not easy to be damaged or broken; There are many specifications, which can give customers more choices; Excellent anti fouling ability and more hygienic wearing; In addition, there is no discomfort after wearing it. Let’s start with teeth with a gorgeous smile.
BionFlex
High Quality Dental Sheets Series
SHORT DESCRIPTION:
Our premium multi-layer TPU sheet is specially designed for clear aligners, offering exceptional durability, flexibility, and comfort. Made from high-quality thermoplastic polyurethane (TPU), this advanced material provides excellent crack resistance, optimal transparency, and superior elasticity, ensuring a perfect fit and long-lasting performance.
With a multi-layer structure, it enhances force retention, resists deformation, and delivers consistent orthodontic correction. The biocompatible and BPA-free composition ensures safety and comfort for patients. Ideal for high-performance clear aligners, our TPU sheet sets a new standard in orthodontic materials.
Application
Legacy orthodontic foils are used for orthodontics. Dentists can formulate special orthodontic schemes according to the orthodontic conditions of patients and then make specific orthodontic braces in each period to achieve the purpose of teeth. Each invisible braces are customized, and it is easy to make them through Legacy orthodontic foils.
Parameters
| Material | TPU |
| Thickness | 0.76mm |
| Width | 125mm/120mm |
| Surface Finish- Surface A | Mirror |
| Surface Finish- Surface B | Mirror |
| Property | Typical Value | Test Method |
| Tensile modulus (MPa) | 1030 | GB/T 1040.3-2006 |
| Yield stress (MPa) | 29.0 | GB/T 1040.3-2006 |
| Yield strain (%) | 6.9 | GB/T 1040.3-2006 |
| Angle tear strength (KN/m) | 153 | GB/T 1040.3-2006 |
| Flexural modulus (MPa) | 1630 | GB/T 9341-2008 |
| Grade | Thickness/ Diameter | Recommended Equipment Settings |
| mm | Scheu MiniStar (Code)/ Drufomat scan (s) | |
| TPU-D125-076 | 0.76 / 125 | Code: 142/ Heating: 1.25 – Cooling time: 1:20 |
| TPU-D120-076 | 0.76 / 120 | Code: 142/ Heating: 1.25 – Cooling time: 1:20 |
Applicable Standards:
| 1. | ISO 15223-1:2021 | Medical devices – symbols to be used with medical device labels, labelling and information to be supplied- part 1: general requirements |
| 2. | EN ISO 20417:2021 | Medical devices. Information to be supplied by the manufacturer |
| 3. | ISO 14971:2019 | Medical devices- Application of risk management to medical devices |
| 4. | EN ISO 10993-1:2020 | Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process |
| 5. | EN ISO 10993-5:2009 | Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity |
| 6. | EN ISO 10993-10:2013 | Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization |
| 7. | EN ISO 10993-23:2021 | Biological evaluation of medical devices- Part 23: Test for irritation |
| 8. | IEC 62366-1:2020 | Medical devices- Application of usability engineering to medical devices |
| 9. | ASTM D 4169-16 | Standard Practice for Performance Testing of Shipping Containers and Systems |
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