SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE— 510(k) K060889

Name: FDA 510(k) clearance K060889
Creator: U.S. Food and Drug Administration
Published: 2006-10-27

Substantially Equivalent

Pentron Clinical Technologies

FDA 510(k) clearance K060889 for SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE, Substantially Equivalent on 2006-10-27. Applicant: Pentron Clinical Technologies. Device class: 2.

Clearance details

Applicant: Pentron Clinical Technologies
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2006-03-31
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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