Taglus® PU Flex

Taglus® PU Flex

"Smartest material properties and enhanced esthetics"

Taglus® PU Flex is a homogeneous polyurethane sheet that consists of linear polymeric chains made of alternating flexible and rigid segments. It is a high-performance aligner and retainer material that provides excellent flexibility, strength, and durability, while also providing comfort for the wearer.

• Highly flexible: Unique formulation results in resulting in higher toughness yet more flexibility
• Comfortable and durable: High value of elongation at break reduces the risk of aligner cracks
• Brilliant wear and tear resistance: Designed for long term wear to withstand tooth forces
• Orthodontic forces: Generates 20% more initial forces Vs other PU materials

ABOUT TAGLUS PU FLEX

Taglus® PU flex comprises of flexible segments that have a low glass transition temperature while the rigid segments exhibit a high melting point. This eliminates the multilayer formation yet achieves all its properties in a single layer. The unique
modification of these phases makes it possible to have properties such as coldflexibility, soft-touch, wear and abrasion resistance, chemical resistance, scratch and tear resistance.

PHYSICAL PROPERTIES

TENSILE STRESS

Taglus® PU Flex sheets have a very high value of elongation at break. With an approximate value of 100%, the material can stretch up to 100 percent of its original dimensions before it breaks, this eliminates the worries of aligner cracking.
In applications where plastic films are designed to withstand orthodontic forces in an aligner, the mechanical properties of polymers namely Strength, Stiffness & Toughness play a vital role. Such properties of Taglus® PU Flex sheets when investigated using standardized test methods, e.g. tensile stress as per ASTM D 638: 2014 by briefly applying load in one direction the approximate results and values observed during such test, demonstrate that Taglus® PU Flex has the highest tensile stress at the break in its class approximately equal to 61 MPa. So, it is an optimal balance of rigidity with
elasticity. The test was performed by a NABL accredited Laboratory complying with ISO/IEC 17025 Laboratory Management System.

IMPACT STRENGTH

Owing to the presence of alternating flexible and rigid segments, the polymer toughness is highly increased. When measured Un-notched Izod Impact Strength as per ASTM D256 @73°F (23°C) in 0.125” thickness, the value was approximately 85 J/m (No Break) indicating it is a virtually unbreakable aligner thermoforming foil.

ELONGATION AT BREAK

Taglus® PU Flex sheets have a very high value of elongation at break. With an approximate value of 100%, the material can stretch up to 100 percent of its original dimensions before it breaks, this eliminates the worries of aligner cracking.

WATER ABSORPTION

The water absorption data is important to understand the performance of the Taglus® PU Flex sheets during processing e.g. Thermoforming as well as in water or humid environments especially in saliva in the mouth, to avoid premature moisture-related failures. Taglus® PU Flex sheets when tested for 24 hours water absorption test exhibited only 0.15% weight changes against the industry-accepted chemical resistance standard of <3%.

CLARITY:

The photographs of Taglus® PU Flex sheets when compared with other PU-based aligner sheets show a noticeable difference in the clarity of the object placed at a distance from the sheet. Taglus® PU Flex sheets have the highest clarity in their class of other PU-based aligner thermoforming foils.

BIOCOMPATIBILITY TESTING

TAGLUS thermoforming files have passed biocompatibility testing namely skin sensitization , in vitro cytotoxicity and skin irritation test as a regulatory requirement for demonstrating the preclinical safety of medical devices, this is evaluated in accordance with the standard guideline, published by the US FDA “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process” which can be accessed at
https://www.fda.gov/media/download, issued on September 4th 2020 and originally published onJune 16th 2016.