tün® ultrasonic tips product family— 510(k) K182145

Name: FDA 510(k) clearance K182145
Creator: U.S. Food and Drug Administration
Published: 2019-06-07

Substantially Equivalent

Engineered Endodontics

FDA 510(k) clearance K182145 for tün® ultrasonic tips product family, Substantially Equivalent on 2019-06-07. Applicant: Engineered Endodontics. Device class: 2.

Clearance details

Applicant: Engineered Endodontics
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2018-08-08
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonee Falls, WI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.