FDA · official record K212229Substantially Equivalent

White Endoseal MTA

Name: White Endoseal MTA — FDA K212229
Creator: Maruchi
Keywords: White Endoseal MTA, White Endoseal MTA, K212229, KIF, FDA

United StatesKIFMaruchi

Verified

Official record identity

FDA application number: K212229
Decision date: August 13, 2021
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Maruchi

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2021-07-16
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.