FLEXI-FLOW CEMENT WITH TITANIUM— 510(k) K922250

Name: FDA 510(k) clearance K922250
Creator: U.S. Food and Drug Administration
Published: 1994-01-26

Substantially Equivalent

Essential Dental Systems, Inc.

FDA 510(k) clearance K922250 for FLEXI-FLOW CEMENT WITH TITANIUM, Substantially Equivalent on 1994-01-26. Applicant: Essential Dental Systems, Inc.. Device class: 2.

Clearance details

Applicant: Essential Dental Systems, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1992-05-06
Decision date: 1994-01-26
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.