Dental implant testing per ISO 14801 uses fatigue testing to ensure the integrity of the implant, simulating a worst case scenario. Our medical device experts can provide you with the dental implant tests necessary for regulatory submission.
ISO 14801 Fatigue Testing for Dental Implants
To compare endosseous dental of various designs and sizes, dental implant developers are required by ISO 14801 to have a certified laboratory undergo fatigue testing. Each implant size and shape must be evaluated in order to receive regulatory approval, necessitating the use of a reliable testing partner familiar with the particular needs of dental implant testing.
Finding the appropriate dental implant testing sets and predicating data for comparison is important because there are numerous configurations for dental implant testing.
To develop a life-cycle curve, dental implants undergo fatigue tests We can calculate the implant’s useful life using this data. The curve is produced by running 2-3 test runs under a variety of loads (usually 4-5), up to the point where at least three specimens can withstand 5 million cycles (2 million if the test is conducted in-vitro) without failing. Most fatigue tests are conducted at 10Hz (2Hz if performed in-vitro).
Although static testing is not covered by ISO ISO 14801, Empirical has the capability to carry out static compression test runs to help determine the starting loads for dental implant testing.
COMPREHENSIVE FATIGUE TESTING FOR DENTAL IMPLANTS
As a well-known expert in testing medical device testing, Empirical has performed numerous tests on dental implants, such as metallurgical evaluation and failure analysis, torque, tension testing, environmental testing and microbiological testing fixed all-ceramic and metal-ceramic dental implants’ integrity is also evaluated using flexural strength testing (ISO 6872).
To assure your success and launch a secure product, our respected medical device professionals work diligently. Contact us right away to learn more information about our dental implant testing or to request a quote.
- ISO 14801: Dentistry – Implants – Dynamic Fatigue Test for Endosseous Dental ImplantsTo