FDA · official record K060889Substantially Equivalent

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

Name: SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE — FDA K060889
Creator: Pentron Clinical Technologies
Keywords: SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE, SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE, K060889, KIF, FDA

United StatesKIFPentron Clinical Technologies

Verified

Official record identity

FDA application number: K060889
Decision date: October 27, 2006
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Pentron Clinical Technologies

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-03-31
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.