ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)— 510(k) K112078

Name: FDA 510(k) clearance K112078
Creator: U.S. Food and Drug Administration
Published: 2012-03-19

Substantially Equivalent

Maruchi

FDA 510(k) clearance K112078 for ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE), Substantially Equivalent on 2012-03-19. Applicant: Maruchi. Device class: 2.

Clearance details

Applicant: Maruchi
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2011-07-21
Decision date: 2012-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, 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.