BionFlex- Multi-layer Thermoplastic Polyurethane (TPU) Material

BionFlex

High Quality Dental Sheets Series

SHORT DESCRIPTION:

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.

Advantages

1. High Toughness

More tough than PETG and PP materials，long-term protection of the orthodontic position

2. Strong Stain Resistance

Perfect solution to stained aligners such as coffee

3. More Options

Available in a variety of sizes to meet the clinical needs of different stages

4. Higher Strength

High hard polyester resin, designed for dentistry

5. Light & durable, more comfortable to wear,

Invisible and brighter smile

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	Frosted

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

Recommended Equipment Settings

Equipment	Settings
BioSTARMiniSTAR/MiniSTAR S	Code	122/132/142
DreveDrufomatScan	Heating	1:10
	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