ENDO-EXPRESS (R) HANDPIECE— 510(k) K111541

Substantially Equivalent

Essential Dental Systems, Inc.

FDA 510(k) clearance K111541 for ENDO-EXPRESS (R) HANDPIECE, Substantially Equivalent on 2012-03-16. Applicant: Essential Dental Systems, Inc..

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code EGS
Advisory panel: Dental
Date received: 2011-06-02
Decision date: 2012-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hackensack, NJ, US

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.