While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.A dhr review was conducted with no discrepancies noted.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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It was reported that a (b)(6) year old male patient experienced an allergic reaction (edema of the lower lip) following a treatment including ceram.X spectra hv/lv.Due to the age of the patient and his medical background, he preferred calling the emergency service, and the patient went to the hospital.He recovered rapidly.
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