Specific patient information with regard to gender, age and weight was not provided.Although the doctor identified three (3) shades associated with the black specks, he could not verify which lot was used on each patient; therefore, no lot numbers were identified in section d-4 of this report.The lots involved in the alleged incidents include lot numbers 5044580, 4819811, and 4814790.The doctor drilled out the composite and repeated the procedure during the same office visit.To date, the patient is doing fine.A visual evaluation was performed on the returned product from each of the lots, yielding results within specifications.In addition, a dhr review indicated that there were no deviations from the manufacturing process.
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