Download presentation
Presentation is loading. Please wait.
Published byArabella Gibbs Modified over 9 years ago
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
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
18
To measure is to know!
19
Output vs input
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
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
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.