MUCOHARD— 510(k) K053516

Name: FDA 510(k) clearance K053516
Creator: U.S. Food and Drug Administration
Published: 2006-01-26

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K053516 for MUCOHARD, Substantially Equivalent on 2006-01-26. Applicant: Parkell, Inc.. Device class: 2.

Clearance details

Applicant: Parkell, Inc.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2005-12-16
Decision date: 2006-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.