Characterization of Extractables in Dental Bite Guards

Medical devices like dental bite guards, used to prevent tooth grinding during sleep, must undergo rigorous risk management to ensure consumer safety. This process, outlined in ISO 10993, involves identifying extractables—chemicals that can be pulled from the device under specific conditions—to determine any potential toxicological risks.

In this case study, researchers evaluated over-the-counter dental bite guards using a dual-instrument workflow. All samples were initially screened with the Pegasus BTX gas chromatograph time-of-flight mass spectrometry (GC-TOFMS) system, which utilized non-target peak finding and deconvolution to identify hundreds of analytes, including antioxidants and lubricants.

For analytes exceeding the Analytical Evaluation Threshold (AET) that remained unknown, the high-resolution power of the Pegasus HRT was employed. This allowed for precise molecular formula determination and tentative structure proposals, such as the identification of N,N’-ethylenedioleamide. By combining sensitive screening with high-resolution confirmation, this analytical strategy provides a comprehensive solution for managing the safety and quality of medical devices.