FILE TYPE H (HEDSTROEM) ENDODONTIC— 510(k) K823685

Substantially Equivalent

United Dental Mfg., Inc.

FDA 510(k) clearance K823685 for FILE TYPE H (HEDSTROEM) ENDODONTIC, Substantially Equivalent on 1982-12-28. Applicant: United Dental Mfg., Inc..

Clearance details

Applicant: United Dental Mfg., Inc.
Product code: Code EKS
Advisory panel: Dental
Date received: 1982-12-07
Decision date: 1982-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.