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BioTec Silicone ready to print. Flexible, elastic and thermosensitive. 3D Print revolution Creation of supports Kind of supports: Cone; Remove supports after postcuring Biocompatibility tests according to: DIN EN ISO 10993-5 Tests for in vitro cytotoxicity (approx. 2 weeks) DIN EN ISO 10993-10 Tests for irritation and skin sensitizations (approx. 3 months) Complete documentation incl. verification and validation according to medical device directive 93/42/EWG (approx. 2 months) Registration for Europe and US: approx. 9 months BioTec as registered product available: approx. Q4/2019 Next steps Facts For direct printing of flexible earmolds without cast form New material composition Flexible silicone for DLP-3D printing Elastic consistency Thermosensitive characteristics www.dreve.com Process Printer with UV LED with 385nm (e.g. Rapid Shape, Asiga) build styles in progress Cleaning in Isopropanol (97%) within a time of approx. 6 minutes (ultra sonic) and afterwards drying with compressed air Post curing PCU LED N 2 Sonolux Flash Evo Mechanical properties Hardness Tensile strength Elongation 50–55 Shore A at 23 °C 45–50 Shore A at 37 °C (DIN ISO 7619-1) 2.5 MPa (DIN 53504) 100% (DIN 53504)
