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FDA 510(k)

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

K-Number: K060889 · 2006-10-27

ApplicantPentron Clinical Technologies
Decision Date2006-10-27
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K060889. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE?

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K060889.

When did SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE receive FDA 510(k) clearance?

SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE received FDA 510(k) clearance on 2006-10-27, under 510(k) number K060889.

Who is the listed applicant for SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE?

The FDA 510(k) record lists Pentron Clinical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE?

The FDA product code for SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE is KIF.

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Related Devices (Code: KIF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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