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Engineered Endodontics, LLC, Menomonee Falls, WI – FDA Inspections

Inspection records and compliance data for Engineered Endodontics, LLC in Menomonee Falls, Wisconsin. 2 FDA inspections on record, 1 Form 483, last inspected August 28, 2025.

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Company Profile

This profile covers Engineered Endodontics, LLC based in Menomonee Falls, Wisconsin, United States.

FDA Inspection History

FDA inspections
2
OAI
0
VAI
1
NAI
1
Form 483s
1
Warning letters
0

First inspected May 23, 2016. Last inspected August 28, 2025.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Documentation1 inspection
  • GUDID Information required for unique device identification.1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
August 28, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1281165
May 23, 2016VAIMedical Devices & Rad Health · Compliance: Devices984573
FDA documents

Form 483s (1)

  • Form 483s · August 28, 2025
People (1)
Shawn Choi
Person
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Company Information

Name

Engineered Endodontics, LLC

FEI Number

3012322979

Address

4965 N. Campbell Drive, Menomonee Falls, Wisconsin 53051, United States

Country

United States

ID: 7db87ff7-c344-48f4-99f8-567f29128e57

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