FDA · official record K112078Substantially Equivalent

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

Name: ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) — FDA K112078
Creator: Maruchi
Keywords: ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE), ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE), K112078, KIF, FDA

United StatesKIFMaruchi

Verified

Official record identity

FDA application number: K112078
Decision date: March 19, 2012
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Maruchi

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-07-21
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.