FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE— 510(k) K855136

Substantially Equivalent

Union Broach, Div. Moyco Industries, Inc.

FDA 510(k) clearance K855136 for FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE, Substantially Equivalent on 1986-03-06. Applicant: Union Broach, Div. Moyco Industries, Inc..

Clearance details

Applicant: Union Broach, Div. Moyco Industries, Inc.
Product code: Code EKS
Advisory panel: Dental
Date received: 1985-12-23
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.