Technology

Equipment

Normadent’s technological equipment consists entirely of machinery from internationally recognized top level suppliers. Our equipment is routinely tested and calibrated, in some cases daily such as the ‘alignment blocks’ which are used to check accuracy before a machine is used. Technology and safety to guarantee a product: this too is Normadent.

The design stage

At Normadent, each new product goes through a thorough design stage, including:
– planning
– collection and analysis of data on the product
– creation and analysis of a prototype
– structural verification carried out by external laboratories
– reassessment of the entire project
– modifications where necessary
– validation

At each stage of design and production, we at Normadent adhere to the relevant company policy, and in particular to the guidelines and regulations of Italian legislative decree 37/10 which implements EEC directive 2007/47/CEE regarding me- dical devices.

Surface treatments

The surfaces of our implants are treated with AL2O3 using sandblasting and then smoothing. The most recent documentation on the subject states that the aluminum dioxide used for the treatment has excellent bio-compatibility and osteo-integration characteristics (HOEDT 1990 .. et al 1992). This procedure enables us to obtain an increase in the bone-implant contact surface up to 3 times higher than a smooth surface. Titanium and AL2O3 (clinically tested materials) obtain the best results in anatomo-biological situations.

Cleaning and disinfection process

This is the pride of our production cycle. Before sterilization, we ensure our products are perfectly washed, cleaned, and disinfected using specially designed equipment. Part of this process is carried out in a laminar flow workstation. This workstation is positioned away from the production area in a special room which is periodically cleaned and maintained. Normadent’s cleaning and disinfection processes have been certified by organizations authorized to carry out microbe contamination tests. The workstation has also been verified by a certified authority.

Sterilization methods

After packaging, which is carried out in a dedicated workplace, all dental implants are subjected to a sterilization cycle using GAMMA rays (25 kgj minimum) by a third party. In accordance with UNI EN 11737-1 (July 2006) standards, each item is then subjected to a bioburden by an authorized agency. This procedure enables us to effectively guarantee the sterility of our products.

Analyses and test

During the certification stage, our implants are subjected to SEMEDX and XPS analyses to evaluate their surface morphology, chemical composition, and cyto-compatibility characteristics. The analyses show that the decontamination process has succeeded in removing any contaminants from the surface and has reached an ideal level of surface cleaning. The repeatability of the treatment is safeguarded by a certified process which enables us to use our system on implants of various geometries. Cytotoxin tests have been carried out by top accredited external laboratories, and have shown a total absence of toxic effects at a single stratum cell level in contact with the screws.