This application note demonstrates a non-targeted analytical workflow for assessing extractables in over-the-counter dental bite guards, following ISO 10993 Part 18 guidelines for medical device risk management. Using the Pegasus® BTX and HRT+ GC-TOFMS systems, volatile and semi-volatile compounds were identified with high sensitivity and resolution. The BTX enabled broad-spectrum screening, while the HRT+ provided accurate mass data to help identify unknown analytes above the analytical evaluation threshold (AET). This combined approach offers powerful tools for characterizing chemical risks in complex medical device samples.

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