Standard of high quality

High quality standard products.

Implants are categorized as Class IIB products, abutments and screws are Class IIA. All these products must comply with the requirements and standard of the Medical Device Directive (MDD93/42/EEC) and its amendments. These include the NEN-EN 1642 and NEN-EN-ISO 14801, which partly prove that all necessary requirements and standards are fullfilled.

All products of Dyna Dental:

  • Feature truthful claims
  • Are subjected to quality controls of 100%
  • Are scientifically and clinically researched and substantiated

The certification and inspection process is controlled by a so called notified body. This is an institute that monitors the compliance of companies to the European guidelines and directives. For manufacturers of dental products there are 3 globally renowned authorities active; DEKRA, BSI and Tüv Sud.

These bodies make sure the quality of the products lives up to the highest standard. DEKRA is the establishment Dyna Dental Engineering B.V. complies to. DEKRA belongs to ‘The European Association of Medical Notified Bodies’ and follows all necessary codes of conduct. 22 other authorities are also affiliated (www.teamnb.org).

 

 

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