Health Canada — Medical Devices · Canada · 2015-07-07 · Type II
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Reported risk: Approximately 10% of dental accounts have reported to 3M that Lava Ultimate Crowns de-bonded at a rate higher than their typical experience for crowns. The reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. Based on this customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
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