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

Source: https://www.keypedia.com/records/483/engineered-endodontics-llc/38d1430c-a487-428a-bf36-41e1356a74c5

> FDA 483 for Engineered Endodontics, LLC on August 28, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Engineered Endodontics, LLC
- Inspection Date: 2025-08-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/engineered-endodontics-llc/7db87ff7-c344-48f4-99f8-567f29128e57

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d