FDA · official record K962885Substantially Equivalent

SEALEX EXTRA ROOT CANAL SEALER

Name: SEALEX EXTRA ROOT CANAL SEALER — FDA K962885
Creator: Baladent
Keywords: SEALEX EXTRA ROOT CANAL SEALER, SEALEX EXTRA ROOT CANAL SEALER, K962885, KIF, FDA

United StatesKIFBaladent

Verified

Official record identity

FDA application number: K962885
Decision date: August 30, 1996
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Baladent

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-07-24
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.