ISO 14801 Test Machine

ISO 14801 test standard describes the technical requirements to fatigue test dental implants. Introducing a new dental implant design to market is a daunting task with an impressive reward for the successful innovator. Dental implants are rising in popularity as the Baby Boomer generation turns to research advances in the dental field. Although the market begs for innovation, researchers must consider many challenges in the face of market approval.

Constrained by deadlines and budgets, you must prove your design and develop your product. The regulatory aspects are challenging and consume time and resources. Typically mechanical static and fatigue tests are not only required of your device but of predicate devices as well. Mechanical tests may be helpful during the research and development phase and are needed to meet regulatory submission requirements of your 510K.

TestResources offers fatigue testing machines with special dental test fixtures to test the fatigue properties of dental implants according to ISO standards and FDA requirements.

Dental Implants are fatigue tested to compare endurance limits (highest fatigue loads the implant systems can withstand without failure) as implant systems use “worst-case scenario” with custom 30-degree angled abutments. Mechanical fatigue tests help determine the durability of a dental implant and its components when subjected to chewing forces and occlusal loads in the applications they face. The frequency and types of mechanical complications are different for each dental implant system.

By means of our fatigue testing expertise and modular product design, we will help find the testing solution that is right for you. Give one of our application engineers a call today for help with creating the best budget and testing plan according to ISO 14801.

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