Engineered Endodontics, LLCAugust 28, 2025

FDA 483 - Engineered Endodontics, LLC - August 28, 2025

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Record Details

Engineered Endodontics, LLC, a repackager/relabeler in Menomonee Falls, WI, was inspected by the FDA. The inspection revealed one observation related to the firm's failure to submit correct unique device identifier (UDI) information for its registered Class I and Class II devices to the Global Unique Device Identification Database (GUDID). This indicates a compliance issue with device identification data submission requirements.

Company: Engineered Endodontics, LLC
Inspection Date: August 28, 2025
Product Type: Device
Office: Minneapolis District Office
Person: Shawn Choi

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ID · 38d1430c-a487-428a-bf36-41e1356a74c5