Material & Quality
Questions
We ensure the consistent quality from the very beginning by choosing only the best materials available. We are also certified by GMP and ISO 13485. Products are CE certified and FDA cleared (Class I for all products and Class II for Osstem series). This mind set is carried throughout our manufacturing process and quality control check. Please refer to QA/QC area on this website.
The material for Ti base, premilled blank abutment, standard and aesthetic abutment and screw is Titanium 6AI-4V Eli, also referred to as the Grade 5 Titanium. The material is from Germany and the United States. The material for scan body is the Peek top with titanium base. Peek is non-reflexive and thus will not require any spray which may influence scanning precision. The material for analog and digital analog is stainless steel.
Grade 5 titanium has many benefit, including the following: Strong Biocompatibility(non-toxic AND integrates well into the body) Non-ferromagnetic Titanium implants have been in use since 1965 and have been highly successful in clinical use.
