Dreve BioTec EN

Post on 07-Feb-2022

5 views 0 download

transcript

BioTecSilicone ready to print.

Flexible, elastic andthermosensitive.

3D Print revolution

Creation of supportsKind 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 documentationincl. verifi cation and validation

according to medical devicedirective 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 fl exible earmolds without cast form

New material composition

Flexible silicone for DLP-3D printing

Elastic consistency

Thermosensitive characteristics

www.dreve.com

ProcessPrinter 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 N2

Sonolux Flash Evo

Mechanical propertiesHardness Tensile strength Elongation50–55 Shore A at 23 °C 45–50 Shore A at 37 °C (DIN ISO 7619-1)

2.5 MPa (DIN 53504)

100%(DIN 53504)