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Engineered Endodontics

FDA Regulatory Profile

Engineered Endodontics has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Aug 28, 2025 · VAI
Latest 510(k)
Jun 7, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 28, 2025Menomonee Falls, WIDevicesVoluntary Action Indicated (VAI)3012322979
May 23, 2016Menomonee Falls, WIDevicesVoluntary Action Indicated (VAI)3012322979

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182145tün® ultrasonic tips product familyJun 7, 2019

FDA data resources