Because the reporting dentist was unable to provide patient-specific information, this report is being made to cover the estimated 100-200 impacted patients.Since this event involved three medical devices, three manufacturer reports are being submitted.This report describes the second device.Manufacturer report numbers 3005174370-2015-00110 and 9611385-2015-00090, describe the first and third device, respectively.
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On (b)(6) 2015, a dentist reported that 100-200 patients with 3m espe lava ultimate cad/cam restorative for cerec crowns required root canal treatment.These crowns were secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive.The reporting dentist declined to provide additional information on the dates of treatments, specific number of patients involved, and current status of patients.
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