DELDENT ULTRASONIC INSERTS— 510(k) K011179

Substantially Equivalent

Deldent , Ltd.

FDA 510(k) clearance K011179 for DELDENT ULTRASONIC INSERTS, Substantially Equivalent on 2001-06-05. Applicant: Deldent , Ltd..

Clearance details

Applicant: Deldent , Ltd.
Product code: Code ELC
Advisory panel: Dental
Date received: 2001-04-17
Decision date: 2001-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikvah, IL

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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.