SOLID CORE GUTTA PERCHA CARRIER— 510(k) K905640

Substantially Equivalent

The Hygenic Corp.

FDA 510(k) clearance K905640 for SOLID CORE GUTTA PERCHA CARRIER, Substantially Equivalent on 1991-03-05. Applicant: The Hygenic Corp..

Clearance details

Applicant: The Hygenic Corp.
Product code: Code EKS
Advisory panel: Dental
Date received: 1990-12-17
Decision date: 1991-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, 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.