ISO 14801: Dental Implant Testing
Get comprehensive ISO 14801 dental implant testing that simulates worst-case conditions for regulatory compliance. Our accredited laboratory validates multiple implant designs with detailed life-cycle curves from strategic test runs at multiple load levels, providing the performance data that streamlines your regulatory approval and ensures product quality validation.
What is ISO 14801 Dental Implant Testing at Element?
ISO 14801 testing requires accredited laboratory performance of fatigue testing to compare endosseous dental implants of different designs and sizes. At Element, we perform these tests to create life-cycle curves that determine implant durability, providing critical data for regulatory submission. Our comprehensive testing approach simulates worst-case conditions to validate implant performance.
What Can Element Offer You For Dental Implant Testing?
Components and materials we test
Components and materials we test
Element tests endosseous dental implants, fixed all-ceramic, and metal-ceramic dental implants across multiple configurations. Our testing capabilities accommodate different designs and sizes required for regulatory approval, with specialized expertise in evaluating various material combinations and structural designs. Each implant undergoes rigorous testing to validate its performance under simulated real-world conditions.
Key tests offered
Key tests offered
We provide comprehensive testing services including fatigue testing at specified frequencies (10Hz standard, 2Hz in-vitro), static compression testing for determining starting loads, metallurgical evaluation, failure analysis, torque testing, environmental analysis, microbiological analysis, and flexural strength testing for fixed all-ceramic and metal-ceramic dental implants following ISO 6872 requirements.
Methods and solutions offered
Methods and solutions offered
Our testing methodology creates detailed life-cycle curves through strategic test runs at multiple load levels. We conduct 2-3 test runs at 4-5 distinct load levels, continuing until three specimens reach 5 million cycles (2 million if performed in-vitro) without failure. This systematic approach provides comprehensive performance data and supports regulatory requirements for implant validation.
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Comprehensive testing solutions
Comprehensive testing solutions
We deliver additional specialized services including metallurgical evaluation, failure analysis, torque testing, tension testing, environmental and microbiological analysis. Our flexural strength testing capabilities for fixed all-ceramic and metal-ceramic dental implants provide complete validation of implant integrity and performance characteristics. While ISO 14801 does not outline static testing, our additional static compression testing capability helps determine appropriate starting loads for your implant testing.
Standards we test to and products we test
- ISO 14801
- ISO 6872
- Endosseous dental implants
- Fixed all-ceramic dental implants
- Metal-ceramic dental implants
- Various implant configurations
- Multiple implant sizes
Your Challenges, Our Solutions
Regulatory compliance navigation
Multiple configurations required
Reliable life-cycle performance data
Managing multiple vendors
Why Choose Element
Medical device leadership
Comprehensive solutions
Testing expertise
Quality focus
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