PRODUCT SPECIFICATIONS Trade Name: Protexsmile® Product characteristics: Pre-packed anatomical mouthguard, suitable for chair side customization with the VDC System® device. Structure of Material: Low crystalline thermoplastic copolymer. Chemical Definition: Ethylene Vinyl Acetate (E.V.A.) copolymer. Class in accordance with directive 93/42/CEE: Class I. Type of use: Device for Protection Against Dental Trauma in Sport. Packaging: Protexsmile® is supplied in two versions Class I and Class II. The package contains: 1 Protexsmile®, 1 VDC System® , 1 Cases and 1 neck laces. ProtexSmile® PROPERTIES OF THE MATERIALS USED IN PRODUCTION ASTM STANDARD MEASUREMENT UNITS VALUES MECHANICAL Hardness Tensile Strength at Break Stress Crack Resistance (F50) Elongation at Break D - 2240 D - 638 D - 1693 D - 638 Shore A N/cm2 hrs % 80 2010 >48 850 THERMAL Vicat Softening Point Low Temperature Brittleness (F50) D - 1525 D - 746 °C °C >45 <-76 BIO-COMPATIBILITY ProtexSmile® is made of material complying to the direction concerning Medical Devices CEE 93/42. As demonstrated by the results of the bio-compatibility testing ( ISO 10993 part 5,10 ), the material is: NON CYTO-TOXIC, NON-IRRITANT AT ORAL MUCOSA LEVEL AND NON-SENSITISING.