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FDA 510(k)

CLEARFIL SILANE KIT

K-Number: K024356 · 2003-03-26

ApplicantKuraray Medical, Inc.
Decision Date2003-03-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL SILANE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2003-03-26 under 510(k) number K024356. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIL SILANE KIT?

CLEARFIL SILANE KIT is a medical device that received FDA 510(k) clearance on 2003-03-26. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K024356.

When did CLEARFIL SILANE KIT receive FDA 510(k) clearance?

CLEARFIL SILANE KIT received FDA 510(k) clearance on 2003-03-26, under 510(k) number K024356.

Who is the listed applicant for CLEARFIL SILANE KIT?

The FDA 510(k) record lists Kuraray Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARFIL SILANE KIT?

The FDA product code for CLEARFIL SILANE KIT is KLE.

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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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