Why an expiration date for Titanium implants ? Part 1
Why An Expiration Date for Titanium Implants? (Part 1)
It has been established as fact that the titanium used for dental implants, in either its pure form or alloyed form, does not have any perishable or corrodible properties. So theoretically, it can sit there in the mouth for hundreds of years without being altered or changed. However, it is known by practitioners that all fixtures that are to be used inside the body, in other words all Class II and Class III Devices as classified by the FDA including dental implants, will come with an “expiration date”. In reality, that expiration date corresponds to the date through which the package of the implant is tested to remain intact.
Dental implants are sold as sterilized. This sterility should be maintained until the time of placement, meaning the “integrity” of the package also must be preserved through this period until the time of placement. Therefore, the expiration date on dental implants corresponds to the expiration date of the package integrity.
Dental implant manufacturers test the packaging of their implants rigorously, so that they can stand against:
1 Normal and physical abuse like the package being shaken and compressed with other packages during transport.
2 Extremely cold temperatures, such as under the freezing conditions of a cargo bay during a transcontinental flight
3 Extremely hot temperatures, such as under the scorching conditions of inside a UPS truck on a hot summer day in Arizona.
4 Time – the packages that have been through these conditions of extreme cold or heat must maintain its integrity for the years that has been indicated on the package.
At Dental Evolutions, we have conducted these tests successfully by an outside FDA and ISO certified laboratory. In our next article, we will discuss the exact tests that were performed on our behalf to validate our packaging.
Written by : Parsa Zadeh, DDS, MAGD