The dream tap was manufactured per physician's prescription.A visual inspection could not be performed as the device was not returned.A batch/lot review for the associated material showed no manufacturing deviations or abnormalities.Per the ifu, "allergic reaction may be encountered.Discontinue use if reaction occurs and consult prescriber." glidewell research team and namsa conducted a series of testing on erkodent material (erkoloc-pro and erkodur) following iso 10993 (biological evaluation of medical devices) and the device was evaluated for potential cytotoxicity, skin irritation, delayed dermal contact sensitization and oral mucosal irritation.The test results were listed and summarized in rpt 9733 rev 1.0.· for cytotoxicity testing, the test article extract showed no evidence of causing cell lysis or toxicity.· for skin irritation, there was no erythema and no edema observed on the skin test.· for sensitization testing, the test article extracts showed no evidence of causing delayed dermal contact sensitization.· the test article showed nonirritant to the oral mucosa as compared to the control article.This complaint will be kept on record for track and trending purposes.
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