According to ISO 14801:2007, dental implant developers must have an accredited laboratory perform fatigue testing to compare endosseous dental implants of different designs and sizes. Each implant size and shape must be tested to pass regulatory approval, necessitating a testing partner who understands the unique requirement of dental implant testing.
The data from the fatigue tests will create a life-cycle curve. The curve is created by performing 2-3 test runs at a series of load levels (typically 4-5), until a lower limit is reached at which at least three specimens reach 5 million cycles (2 million if performed in-vitro) without failure. Fatigue testing is typically performed at 10Hz (2Hz if performed in-vitro).
ISO 14801 does not outline static testing, however, Element has the capability to perform static compression test runs on dental implants to assist in determining starting loads for fatigue testing.
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Maciej has over 10 years of experience in medical device testing and analysis for FDA 510(k) and CE submissions.
Kent is the co-founder of Medical Device Testing Services, acquired by Element in 2017. Kent’s expertise in medical device testing has led to the development of new test instruments, standards and protocols.