As allowed by exemption# e2012008, heraeus kulzer llc (the importer) is submitting the report on behalf of heraeus kulzer gmbh (the manufacturer).Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Narrative-device has not been returned and lot number is not known.Analysis of directions for use state: the use of this product is contraindicated in case of known or suspected allergies against (meth) acrylate compounds.H3 other text: not returned, no lot number.
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