FDA requires additional test procedure long used by CleanImplant
On October 15, 2024, the US Food and Drug Administration (FDA) published a new guidance document for the simplified approval of dental implants. In addition to the well-known toxicological tests (ISO 10993-5), this guidance document demands a “surface cleanliness analysis” for the first time and thus focuses on the possible immunological effects of particulate contamination.
The guidance document defines various “performance criteria for the safety of endosseous dental implants”. For the required “surface cleanliness analysis”, the „analysis of the surface of the implant body should be carried out using a scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS), which enables an enlarged view of the implant surface and the determination of the elemental composition of the surface. The magnified images should be of sufficient magnification to show the entire representative surface of the implant.“
We are grateful that the FDA recognizes the comprehensive testing procedure developed by our group back in 2016 for a long series of quality assessment studies.
One of the collaborating testing laboratories is the medical materials research institute “MMRI” in Berlin, Germany (www.mmri.berlin). The laboratory is specialized in implant quality analysis and is officially accredited according to ILAC-MRA (International Laboratory Accreditation Cooperation) and DIN EN ISO/IEC 17025:2018.
The research institute provides a unique SEM mapping-image that is electronically compiled from hundreds of single SEM images, showing the complete implant sample from shoulder to apex in an extremely high resolution. The comprehensive MMRI reports can prove a clean implant production or reveal manufacturer quality management deficits.
Example of a comprehensive testing report with SEM image magnifications up to 5,000x and elemental analysis by Energy Dispersive X-ray Spectroscopy (EDS) according to ISO 22309:2015.
Two sterile-packaged dental implants show a different level of cleanliness in the SEM-mapping image, digitally composed from up to 600 single SEM images.
