SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL— 510(k) K110484

Name: FDA 510(k) clearance K110484
Creator: U.S. Food and Drug Administration
Published: 2011-05-17

Substantially Equivalent

Novocol, Inc.

FDA 510(k) clearance K110484 for SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL, Substantially Equivalent on 2011-05-17. Applicant: Novocol, Inc.. Device class: 2.

Clearance details

Applicant: Novocol, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2011-02-18
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, 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.