EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM— 510(k) K063856

Name: FDA 510(k) clearance K063856
Creator: U.S. Food and Drug Administration
Published: 2007-02-06

Substantially Equivalent

Essential Dental Systems, Inc.

FDA 510(k) clearance K063856 for EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM, Substantially Equivalent on 2007-02-06. Applicant: Essential Dental Systems, Inc.. Device class: 2.

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2006-12-28
Decision date: 2007-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.