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Our materials Freedom of choice Tray Gingiva Mask, Model & Model Ortho.

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Presentation on theme: "Our materials Freedom of choice Tray Gingiva Mask, Model & Model Ortho."— Presentation transcript:

1

2 Our materials

3 Freedom of choice

4 Tray

5 Gingiva Mask, Model & Model Ortho

6 Base

7 C&B and C&B MFH

8 Surgical Guide

9 Ortho Rigid, Ortho Clear & Ortho IBT

10 Cast

11 Post curing

12 Research & Development

13

14 Physical properties ISO en ASTM standards related to dentistry of medical devices Charpy Impact Strength Flexural Strength & Modulus Fracture Toughness Total Fracture Work Maximum Stress Intensity Factor Elongation to Break Tensile Strength Compressive Strength Vickers Hardness Shore A&D Tear Resistance Water Sorption & Solubility Residual Monomer Wear Resistance Crazing

15 Onze materialen

16

17

18 To measure is to know!

19 Output vs input

20

21

22 Biocompatibility

23 Cytotoxicity Sensitization Irritation Intracutaneos Reactivity Systemic & Subchronic Toxicity Genotoxicity Implantation Heamacompatibility Sterilisation Design Stability Wear Resistance Food Resistance Leachables Comfort Fit Biocompatibility & Clinical characteristics ISO en ASTM norms, incl. ISO 10993

24 mat Biological evaluation acc. ISO 10993 erialen

25

26 Clinical studies

27 Studies in cooperation with R&D partners Crown & Bridge C&B in- and onlays Splints & Retainers Orthodontic Regulators Surgical Guides Cranio Facial Devices Implants

28 R&D partners TNO Additive Manufacturing, Eindhoven ACTA – Academic Centre Dentistry University, Amsterdam VU - Medical University, Amsterdam AMC - Medical University, Amsterdam RUMC - Radboud Medical University, Nijmegen UMC – Utrecht Medical Center, Utrecht KUL – Royal University Leuven, Belgium Fontys Applied Science, Eindhoven HU Chemical Technology, Utrecht

29 Regulatory

30 Legislations worldwide Medical Device Directive – 93/42/EEC International registrations; FDA PAL CAMCDS SFDA KFDS TPG etc. Support to RA of distributors


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