Boca Dental Regenerative LLCJune 5, 2023

FDA 483 - Boca Dental Regenerative LLC - June 05, 2023

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Record Details

Boca Dental Regenerative LLC, a manufacturer in Boca Raton, FL, was inspected by the FDA from May 22 to June 5, 2023. The inspection resulted in one observation regarding incomplete complaint investigation records. Specifically, four out of five complaints received between 2021 and 2023 lacked a unique device identifier (UDI).

Company: Boca Dental Regenerative LLC
Inspection Date: June 5, 2023
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

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ID · 1077d122-e5df-4859-a1ac-49d44c2c3b7e