FDA · official record K073218Substantially Equivalent

MTA ADVANCED MATERIAL

Name: MTA ADVANCED MATERIAL — FDA K073218
Creator: Dentsply Interntional
Keywords: MTA ADVANCED MATERIAL, MTA ADVANCED MATERIAL, K073218, KIF, FDA

United StatesKIFDentsply Interntional

Verified

Official record identity

FDA application number: K073218
Decision date: January 07, 2008
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Dentsply Interntional

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-11-15
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.